Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97530

15 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 28, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 15

Biograph mMR. Model Number: 10433372.

Z-2654-2025
Recall number
Z-2654-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10433372. UDI Number: (01)04056869006741(21)151032, (01)04056869006741(21)151057, (01)04056869006741(21)510535, (01)04056869006741(21)151034, (01)04056869006741(21)51003, (01)04056869006741(21)151021, (01)04056869006741(21)51055, (01)04056869006741(21)151013, (01)04056869006741(21)51064, (01)04056869006741(21)151044, (01)04056869006741(21)51038, (01)04056869245188(21)51006, (01)04056869006741(21)51030, (01)04056869006741(21)151004, (01)04056869006741(21)51022, (01)04056869006741(21)151049, (01)04056869006741(21)51007, (01)04056869006741(21)151045, (01)04056869006741(21)51032, (01)04056869006741(21)51057, (01)04056869006741(21)51015, (01)04056869006741(21)151025, (01)04056869006741(21)51048, (01)04056869006741(21)51062, (01)04056869006741(21)51010, (01)04056869006741(21)51051. Serial Numbers: 151032, 151057, 51053, 151034, 51003, 151021, 51055, 151013, 51064, 151044, 51038, 51006, 51030, 151004, 51022, 151049, 51007, 151045, 51032, 51057, 51015, 151025, 51048, 51062, 51010, 51051. Additional serial number added 01/23/2026: 51007.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 2 of 15

BIOGRAPH One (DE). Model Number: 11689172.

Z-2655-2025
Recall number
Z-2655-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11689172. UDI Numbers: (01)4068151020472(21)238008. Serial Number: 238008.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 3 of 15

MAGNETOM Cima.X (DE). Model Number: 11647158.

Z-2656-2025
Recall number
Z-2656-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11647158. UDI Numbers: (01)04056869975221(21)213029, (01)04056869975221(21)213006, (01)04056869975221(21)213062, (01)04056869975221(21)213043, (01)04056869975221(21)213041, (01)04056869975221(21)213034, (01)04056869975221(21)213035, (01)04056869975221(21)213028, (01)04056869975221(21)213031, (01)04056869975221(21)213018, (01)04056869975221(21)213061, (01)04056869975221(21)213005, (01)04056869975221(21)213021, (01)04056869975221(21)213022, (01)04056869975221(21)213056, (01)04056869975221(21)213030, (01)04056869975221(21)213039, (01)04056869975221(21)213025, (01)04056869975221(21)213063, (01)04056869975221(21)213057, (01)04056869975221(21)213026, (01)04056869975221(21)213020. Serial Numbers: 213029, 213006, 213062, 213043, 213041, 213034, 213035, 213028, 213031, 213018, 213061, 213005, 213021, 213022, 213056, 213030, 213039, 213025, 213063, 213057, 213026, 213020.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 4 of 15

MAGNETOM Connectom.X. Model Number: 11371480.

Z-2657-2025
Recall number
Z-2657-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11371480. UDI Numbers: N/A. Serial Numbers: 237551.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 5 of 15

MAGNETOM Lumina (DE). Model Number: 11344916.

Z-2658-2025
Recall number
Z-2658-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
130 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11344916. UDI Numbers: (01)04056869230740(21)196458, (01)04056869230740(21)196591, (01)04056869230740(21)196655, (01)04056869230740(21)196355, (01)04056869230740(21)196733, (01)04056869230740(21)196668, (01)04056869230740(21)196477, (01)04056869230740(21)196343, (01)04056869230740(21)196553, (01)04056869230740(21)196519, (01)04056869230740(21)196366, (01)04056869230740(21)196782, (01)04056869230740(21)196617, (01)04056869230740(21)196684, (01)04056869230740(21)196502, (01)04056869230740(21)196539, (01)04056869230740(21)196280, (01)04056869230740(21)196626, (01)04056869230740(21)196511, (01)04056869230740(21)196643, (01)04056869230740(21)196796, (01)04056869230740(21)196551, (01)04056869230740(21)196495, (01)04056869230740(21)196741, (01)04056869230740(21)196621, (01)04056869230740(21)196611, (01)04056869230740(21)196544, (01)04056869230740(21)196724, (01)04056869230740(21)196776, (01)04056869230740(21)196752, (01)04056869230740(21)196372, (01)04056869230740(21)196350, (01)04056869230740(21)196841, (01)04056869230740(21)196252, (01)04056869230740(21)196508, (01)04056869230740(21)196332, (01)04056869230740(21)196496, (01)04056869230740(21)196753, (01)04056869230740(21)196375, (01)04056869230740(21)196738, (01)04056869230740(21)196260, (01)04056869230740(21)196470, (01)04056869230740(21)196765, (01)04056869230740(21)196334, (01)04056869230740(21)196288, (01)04056869230740(21)196409, (01)04056869230740(21)196737, (01)04056869230740(21)196286, (01)04056869230740(21)196604, (01)04056869230740(21)196446, (01)04056869230740(21)196362, (01)04056869230740(21)196518, (01)04056869230740(21)196619, (01)04056869230740(21)196450, (01)04056869230740(21)196678, (01)04056869230740(21)196349, (01)04056869230740(21)196261, (01)04056869230740(21)196415, (01)04056869230740(21)196386, (01)04056869230740(21)196391, (01)04056869230740(21)196537, (01)04056869230740(21)196649, (01)04056869230740(21)196411, (01)04056869230740(21)196353, (01)04056869230740(21)196629, (01)04056869230740(21)196403, (01)04056869230740(21)196529, (01)04056869230740(21)196622, (01)04056869230740(21)196414, (01)04056869230740(21)196778, (01)04056869230740(21)196308, (01)04056869230740(21)196768, (01)04056869230740(21)196791, (01)04056869230740(21)196832, (01)04056869230740(21)196606, (01)04056869230740(21)196240, (01)04056869230740(21)196730, (01)04056869230740(21)196360, (01)04056869230740(21)196466, (01)04056869230740(21)196831, (01)04056869230740(21)196789, (01)04056869230740(21)196780, (01)04056869230740(21)196779, (01)04056869230740(21)196405, (01)04056869230740(21)196625, (01)04056869230740(21)196376, (01)04056869230740(21)196703, (01)04056869230740(21)196828, (01)04056869230740(21)196522, (01)04056869230740(21)196570, (01)04056869230740(21)196422, (01)04056869230740(21)196800, (01)04056869230740(21)196775, (01)04056869230740(21)196795, (01)04056869230740(21)196514, (01)04056869230740(21)196565, (01)04056869230740(21)196586, (01)04056869230740(21)196451, (01)04056869230740(21)196525, (01)04056869230740(21)196326, (01)04056869230740(21)196463, (01)04056869230740(21)196331, (01)04056869230740(21)196413, (01)04056869230740(21)196634, (01)04056869230740(21)196746, (01)04056869230740(21)196359, (01)04056869230740(21)196461, (01)04056869230740(21)196330, (01)04056869230740(21)196750, (01)04056869230740(21)196354, (01)04056869230740(21)196557, (01)04056869230740(21)196321, (01)04056869230740(21)196688, (01)04056869230740(21)196818, (01)04056869230740(21)196338, (01)04056869230740(21)196772, (01)04056869230740(21)196472, (01)04056869230740(21)196651, (01)04056869230740(21)196440, (01)04056869230740(21)196687, (01)04056869230740(21)196509, (01)04056869230740(21)196799, (01)04056869230740(21)196549, (01)04056869230740(21)196717, (01)04056869230740(21)196398, (01)04056869230740(21)196367, (01)04056869230740(21)196823, (01)04056869230740(21)196830, (01)04056869230740(21)196464, (01)04056869230740(21)196815. Serial Numbers: 196458, 196591, 196655, 196355, 196733, 196668, 196477, 196343, 196553, 196519, 196366, 196782, 196617, 196684, 196502, 196539, 196280, 196626, 196511, 196643, 196796, 196551, 196495, 196741, 196621, 196611, 196544, 196724, 196776, 196752, 196372, 196350, 196841, 196252, 196508, 196332, 196496, 196753, 196375, 196738, 196260, 196470, 196765, 196334, 196288, 196409, 196737, 196286, 196604, 196446, 196362, 196518, 196619, 196450, 196678, 196349, 196261, 196415, 196386, 196391, 196537, 196649, 196411, 196353, 196629, 196403, 196529, 196622, 196414, 196778, 196308, 196768, 196791, 196832, 196606, 196240, 196730, 196360, 196466, 196831, 196789, 196780, 196779, 196405, 196625, 196376, 196703, 196828, 196522, 196570, 196422, 196800, 196775, 196795, 196514, 196565, 196586, 196451, 196525, 196326, 196463, 196331, 196413, 196634, 196746, 196359, 196461, 196330, 196750, 196354, 196557, 196321, 196688, 196818, 196338, 196772, 196472, 196651, 196440, 196687, 196509, 196799, 196549, 196717, 196398, 196367, 196823, 196830, 196464, 196815.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 6 of 15

MAGNETOM Prisma. Model Number: 10849582.

Z-2659-2025
Recall number
Z-2659-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
101 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10849582. UDI Numbers: (01)04056869006727(21)166324, (01)04056869006727(21)66104, (01)04056869006727(21)166097, (01)04056869006727(21)166024, (01)04056869006727(21)166018, (01)04056869006727(21)66109, (01)04056869006727(21)66111, (01)04056869006727(21)166114, (01)04056869006727(21)166242, (01)04056869006727(21)166268, (01)04056869006727(21)166200, (01)04056869006727(21)166047, (01)04056869006727(21)66047, (01)04056869006727(21)166292, (01)04056869006727(21)166041, (01)04056869006727(21)166007, (01)04056869006727(21)166037, (01)04056869006727(21)66112, (01)04056869006727(21)166025, (01)04056869006727(21)166003, (01)04056869006727(21)66102, (01)04056869006727(21)166254, (01)04056869006727(21)166074, (01)04056869006727(21)166281, (01)04056869006727(21)166220, (01)04056869006727(21)66027, (01)04056869006727(21)166221, (01)04056869006727(21)166321, (01)04056869006727(21)166193, (01)04056869006727(21)166012, (01)04056869006727(21)166121, (01)04056869006727(21)66053, (01)04056869006727(21)166160, (01)04056869006727(21)66094, (01)04056869006727(21)166310, (01)04056869006727(21)66028, (01)04056869006727(21)166102, (01)04056869006727(21)166034, (01)04056869006727(21)166030, (01)04056869006727(21)66106, (01)04056869006727(21)166235, (01)04056869006727(21)166273, (01)04056869006727(21)166201, (01)04056869006727(21)166345, (01)04056869006727(21)166225, (01)04056869006727(21)66044, (01)04056869006727(21)66018, (01)04056869006727(21)166006, (01)04056869006727(21)166009, (01)04056869006727(21)166295, (01)04056869006727(21)166227, (01)04056869006727(21)166188, (01)04056869006727(21)166046, (01)04056869006727(21)166296, (01)04056869006727(21)166298, (01)04056869006727(21)66022, (01)04056869006727(21)66057, (01)04056869006727(21)166326, (01)04056869006727(21)166327, (01)04056869006727(21)166048, (01)04056869006727(21)166289, (01)04056869006727(21)166049, (01)04056869006727(21)66069, (01)04056869006727(21)166040, (01)04056869006727(21)166039, (01)04056869006727(21)166017, (01)04056869006727(21)66092, (01)04056869006727(21)66105, (01)04056869006727(21)166224, (01)04056869006727(21)166319, (01)04056869006727(21)166014, (01)04056869006727(21)166239, (01)04056869006727(21)66046, (01)04056869006727(21)66082, (01)04056869006727(21)166362, (01)04056869006727(21)166179, (01)04056869006727(21)166019, (01)04056869006727(21)166311, (01)04056869006727(21)166330, (01)04056869006727(21)166133, (01)04056869006727(21)166210, (01)04056869006727(21)166285, (01)04056869006727(21)166162, (01)04056869006727(21)66096, (01)04056869006727(21)166082, (01)04056869006727(21)166083, (01)04056869006727(21)66059, (01)04056869006727(21)166084, (01)04056869006727(21)166250, (01)04056869006727(21)166023, (01)04056869006727(21)166272, (01)04056869006727(21)166090, (01)04056869006727(21)166038, (01)04056869006727(21)166158, (01)04056869006727(21)166315, (01)04056869006727(21)166091, (01)04056869006727(21)166313, (01)04056869006727(21)166307, (01)04056869006727(21)166033, (01)04056869006727(21)166010, (01)04056869006727(21)166011. Serial Numbers: 166324, 66104, 166097, 166024, 166018, 66109, 66111, 166114, 166242, 166268, 166200, 166047, 66047, 166292, 166041, 166007, 166037, 66112, 166025, 166003, 66102, 166254, 166074, 166281, 166220, 66027, 166221, 166321, 166193, 166012, 166121, 66053, 166160, 66094, 166310, 66028, 166102, 166034, 166030, 66106, 166235, 166273, 166201, 166345, 166225, 66044, 66018, 166006, 166009, 166295, 166227, 166188, 166046, 166296, 166298, 66022, 66057, 166326, 166327, 166048, 166289, 166049, 66069, 166040, 166039, 166017, 66092, 66105, 166224, 166319, 166014, 166239, 66046, 66082, 166362, 166179, 166019, 166311, 166330, 166133, 166210, 166285, 166162, 66096, 166082, 166083, 66059, 166084, 166250, 166023, 166272, 166090, 166038, 166158, 166315, 166091, 166313, 166307, 166033, 166010, 166011.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 7 of 15

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

Z-2660-2025
Recall number
Z-2660-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
586 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10432915. UDI Numbers: (01)04056869006703(21)45046, (01)04056869006703(21)45115, (01)04056869006703(21)45398, (01)04056869006703(21)145760, (01)04056869006703(21)145811, (01)04056869006703(21)45549, (01)04056869006703(21)45834, (01)04056869006703(21)146099, (01)04056869006703(21)146110, (01)04056869006703(21)45047, (01)04056869006703(21)146093, (01)04056869006703(21)46066, (01)04056869006703(21)45788, (01)04056869006703(21)146082, (01)04056869006703(21)45124, (01)04056869006703(21)45185, (01)04056869006703(21)45332, (01)04056869006703(21)45466, (01)04056869006703(21)145390, (01)04056869006703(21)45732, (01)04056869006703(21)45918, (01)04056869006703(21)45380, (01)04056869006703(21)46182, (01)04056869006703(21)45735, (01)04056869006703(21)45233, (01)04056869006680(21)162026, (01)04056869006703(21)145008, (01)04056869006703(21)145473, (01)04056869006703(21)145095, (01)04056869006703(21)145664, (01)04056869006703(21)45200, (01)04056869006703(21)146098, (01)04056869006703(21)146086, (01)04056869006703(21)45805, (01)04056869006703(21)45812, (01)04056869006703(21)45397, (01)04056869006703(21)46264, (01)04056869006703(21)45499, (01)04056869006703(21)45749, (01)04056869006703(21)45289, (01)04056869006703(21)46220, (01)04056869006703(21)45369, (01)04056869006703(21)45267, (01)04056869006703(21)45253, (01)04056869006703(21)45060, (01)04056869006703(21)146103, (01)04056869006703(21)45333, (01)04056869006703(21)146123, (01)04056869006703(21)46147, (01)04056869006703(21)145721, (01)04056869006703(21)145840, (01)04056869006703(21)145088, (01)04056869006703(21)146124, (01)04056869006703(21)45841, (01)04056869006703(21)45890, (01)04056869006703(21)46295, (01)04056869006703(21)45306, (01)04056869006703(21)45519, (01)04056869006703(21)145905, (01)04056869006703(21)46242, (01)04056869006703(21)145806, (01)04056869006703(21)46171, (01)04056869006703(21)45148, (01)04056869006703(21)45152, (01)04056869006703(21)46194, (01)04056869006703(21)145152, (01)04056869006703(21)45119, (01)04056869006703(21)46207, (01)04056869006703(21)145549, (01)04056869006703(21)45402, (01)04056869006703(21)145090, (01)04056869006703(21)145681, (01)04056869006703(21)45877, (01)04056869006703(21)45693, (01)04056869006703(21)45679, (01)04056869006703(21)146067, (01)04056869006703(21)45140, (01)04056869006703(21)46163, (01)04056869006703(21)145635, (01)04056869006703(21)46028, (01)04056869006703(21)45138, (01)04056869006703(21)46282, (01)04056869006703(21)45479, (01)04056869006703(21)45496, (01)04056869006703(21)45143, (01)04056869006703(21)45314, (01)04056869006703(21)45368, (01)04056869006703(21)46268, (01)04056869006703(21)45998, (01)04056869006703(21)145423, (01)04056869006703(21)145190, (01)04056869006703(21)145377, (01)04056869006703(21)46005, (01)04056869006703(21)45886, (01)04056869006703(21)45905, (01)04056869006703(21)145706, (01)04056869006703(21)145684, (01)04056869006703(21)45990, (01)04056869006703(21)145063, (01)04056869006703(21)146119, (01)04056869006703(21)46260, (01)04056869006703(21)45118, (01)04056869006703(21)145062, (01)04056869006703(21)45506, (01)04056869006703(21)145528, (01)04056869006703(21)145547, (01)04056869006703(21)46206, (01)04056869006703(21)145552, (01)04056869006703(21)45129, (01)04056869006703(21)145330, (01)04056869006703(21)45910, (01)04056869006703(21)145128, (01)04056869006703(21)145750, (01)04056869006703(21)45976, (01)04056869006703(21)145688, (01)04056869006703(21)45182, (01)04056869006703(21)145497, (01)04056869006703(21)45411, (01)04056869006703(21)145150, (01)04056869006703(21)45213, (01)04056869006703(21)145115, (01)04056869006703(21)45683, (01)04056869006703(21)145672, (01)04056869006703(21)145526, (01)04056869006703(21)45737, (01)04056869006703(21)45753, (01)04056869006703(21)145041, (01)04056869006703(21)145042, (01)04056869006703(21)45339, (01)04056869006703(21)45338, (01)04056869006703(21)145040, (01)04056869006703(21)145167, (01)04056869006703(21)45403, (01)04056869006703(21)145799, (01)04056869006703(21)145843, (01)04056869006703(21)145658, (01)04056869006703(21)145086, (01)04056869006703(21)45197, (01)04056869006703(21)45196, (01)04056869006703(21)145108, (01)04056869006703(21)46203, (01)04056869006703(21)145414, (01)04056869006703(21)46027, (01)04056869006703(21)145301, (01)04056869006703(21)45988, (01)04056869006703(21)45279, (01)04056869006703(21)145384, (01)04056869006703(21)145596, (01)04056869006703(21)45881, (01)04056869006703(21)145568, (01)04056869006703(21)45942, (01)04056869006703(21)146085, (01)04056869006703(21)145685, (01)04056869006703(21)145674, (01)04056869006703(21)45088, (01)04056869006703(21)145862, (01)04056869006703(21)45095, (01)04056869006703(21)45676, (01)04056869006703(21)46144, (01)04056869006703(21)45108, (01)04056869006703(21)145300, (01)04056869006703(21)46044, (01)04056869006703(21)46169, (01)04056869006703(21)45537, (01)04056869006703(21)145026, (01)04056869006703(21)46290, (01)04056869006703(21)145758, (01)04056869006703(21)45084, (01)04056869006703(21)145270, (01)04056869006703(21)146117, (01)04056869006703(21)146092, (01)04056869006703(21)45195, (01)04056869006703(21)145631, (01)04056869006703(21)45684, (01)04056869006703(21)45940, (01)04056869006703(21)146114, (01)04056869006703(21)145666, (01)04056869006703(21)145380, (01)04056869006703(21)145816, (01)04056869006703(21)45120, (01)04056869006703(21)145921, (01)04056869006703(21)145842, (01)04056869006703(21)145554, (01)04056869006703(21)46232, (01)04056869006703(21)45135, (01)04056869006703(21)145710, (01)04056869006703(21)145044, (01)04056869006703(21)145686, (01)04056869006703(21)46279, (01)04056869006703(21)145638, (01)04056869006703(21)145367, (01)04056869006703(21)145170, (01)04056869006703(21)145689, (01)04056869006703(21)145187, (01)04056869006703(21)45495, (01)04056869006703(21)45298, (01)04056869006703(21)145164, (01)04056869006703(21)46176, (01)04056869006703(21)45399, (01)04056869006703(21)46261, (01)04056869006703(21)145334, (01)04056869006703(21)145633, (01)04056869006703(21)45375, (01)04056869006703(21)45351, (01)04056869006703(21)146128, (01)04056869006703(21)45276, (01)04056869006703(21)46179, (01)04056869006703(21)145610, (01)04056869006703(21)46048, (01)04056869006703(21)145810, (01)04056869006703(21)46168, (01)04056869006703(21)46121, (01)04056869006703(21)45705, (01)04056869006703(21)45284, (01)04056869006703(21)145669, (01)04056869006703(21)145831, (01)04056869006703(21)145206, (01)04056869006703(21)145667, (01)04056869006703(21)45477, (01)04056869006703(21)145104, (01)04056869006703(21)45112, (01)04056869006703(21)146075, (01)04056869006703(21)145445, (01)04056869006703(21)46032, (01)04056869006703(21)145544, (01)04056869006703(21)46050, (01)04056869006703(21)45212, (01)04056869006703(21)46276, (01)04056869006703(21)145687, (01)04056869006703(21)145099, (01)04056869006703(21)145256, (01)04056869006703(21)46161, (01)04056869006703(21)46020, (01)04056869006703(21)45761, (01)04056869006703(21)145338, (01)04056869006703(21)45736, (01)04056869006703(21)145541, (01)04056869006703(21)145545, (01)04056869006703(21)145259, (01)04056869006703(21)145952, (01)04056869006703(21)46149, (01)04056869006703(21)45149, (01)04056869006703(21)45407, (01)04056869006703(21)45327, (01)04056869006703(21)45944, (01)04056869006703(21)45006, (01)04056869006703(21)45371, (01)04056869006703(21)46238, (01)04056869006703(21)145130, (01)04056869006703(21)45983, (01)04056869006703(21)46189, (01)04056869006703(21)145700, (01)04056869006703(21)45236, (01)04056869006703(21)45201, (01)04056869006703(21)145747, (01)04056869006703(21)46273, (01)04056869006703(21)45520, (01)04056869006703(21)145774, (01)04056869006703(21)46303, (01)04056869006703(21)45116, (01)04056869006703(21)145262, (01)04056869006703(21)145663, (01)04056869006703(21)45456, (01)04056869006703(21)45624, (01)04056869006703(21)145754, (01)04056869006703(21)45599, (01)04056869006703(21)145148, (01)04056869006703(21)45690, (01)04056869006703(21)45963, (01)04056869006703(21)45346, (01)04056869006703(21)45995, (01)04056869006703(21)45293, (01)04056869006703(21)145179, (01)04056869006703(21)45770, (01)04056869006703(21)145161, (01)04056869006703(21)145145, (01)04056869006703(21)145620, (01)04056869006703(21)145476, (01)04056869006703(21)46127, (01)04056869006703(21)45435, (01)04056869006703(21)45155, (01)04056869006703(21)46047, (01)04056869006703(21)45295, (01)04056869006703(21)45160, (01)04056869006703(21)45603, (01)04056869006703(21)145892, (01)04056869006703(21)45543, (01)04056869006703(21)45847, (01)04056869006703(21)145269, (01)04056869006703(21)145770, (01)04056869006703(21)46259, (01)04056869006703(21)45817, (01)04056869006703(21)145827, (01)04056869006703(21)45856, (01)04056869006703(21)45526, (01)04056869006703(21)145731, (01)04056869006703(21)145640, (01)04056869006703(21)145266, (01)04056869006703(21)45117, (01)04056869006703(21)45324, (01)04056869006703(21)45968, (01)04056869006703(21)145775, (01)04056869006703(21)45372, (01)04056869006703(21)145454, (01)04056869006703(21)45249, (01)04056869006703(21)45958, (01)04056869006703(21)145343, (01)04056869006703(21)145255, (01)04056869006703(21)145110, (01)04056869006703(21)46286, (01)04056869006703(21)145609, (01)04056869006703(21)145790, (01)04056869006703(21)145030, (01)04056869006703(21)145011, (01)04056869006703(21)145012, (01)04056869006703(21)145105, (01)04056869006703(21)45219, (01)04056869006703(21)145061, (01)04056869006703(21)145533, (01)04056869006703(21)145532, (01)04056869006703(21)45774, (01)04056869006703(21)45167, (01)04056869006703(21)45069, (01)04056869006703(21)146105, (01)04056869006703(21)145924, (01)04056869006703(21)145113, (01)04056869006703(21)45085, (01)04056869006703(21)45741, (01)04056869006703(21)45147, (01)04056869006703(21)145193, (01)04056869006703(21)46289, (01)04056869006703(21)145622, (01)04056869006703(21)45121, (01)04056869006703(21)45150, (01)04056869006703(21)46175, (01)04056869006703(21)45536, (01)04056869006703(21)46237, (01)04056869006703(21)145032, (01)04056869006703(21)46191, (01)04056869006703(21)46143, (01)04056869006703(21)45733, (01)04056869006703(21)46081, (01)04056869006703(21)45158, (01)04056869006703(21)45110, (01)04056869006703(21)145492, (01)04056869006703(21)46100, (01)04056869006703(21)45379, (01)04056869006703(21)45318, (01)04056869006703(21)145394, (01)04056869006703(21)45681, (01)04056869006703(21)145886, (01)04056869006703(21)145491, (01)04056869006703(21)45425, (01)04056869006703(21)145761, (01)04056869006703(21)45031, (01)04056869006703(21)145632, (01)04056869006703(21)145182, (01)04056869006703(21)145124, (01)04056869006703(21)45996, (01)04056869006703(21)45107, (01)04056869006703(21)45428, (01)04056869006703(21)45635, (01)04056869006703(21)46021, (01)04056869006703(21)46007, (01)04056869006703(21)46105, (01)04056869006703(21)46142, (01)04056869006703(21)45203, (01)04056869006703(21)45018, (01)04056869006703(21)145850, (01)04056869006703(21)146102, (01)04056869006703(21)146100, (01)04056869006703(21)45019, (01)04056869006703(21)145826, (01)04056869006703(21)145521, (01)04056869006703(21)145860, (01)04056869006703(21)45417, (01)04056869006703(21)45928, (01)04056869006703(21)145097, (01)04056869006703(21)145323, (01)04056869006703(21)46205, (01)04056869006703(21)145325, (01)04056869006703(21)45906, (01)04056869006703(21)146115, (01)04056869006703(21)45815, (01)04056869006703(21)45042, (01)04056869006703(21)145594, (01)04056869006703(21)145801, (01)04056869006703(21)45500, (01)04056869006703(21)45986, (01)04056869006703(21)45202, (01)04056869006703(21)45553, (01)04056869006703(21)45381, (01)04056869006703(21)145020, (01)04056869006703(21)45566, (01)04056869006703(21)145990, (01)04056869006703(21)145728, (01)04056869006703(21)45959, (01)04056869006703(21)46009, (01)04056869006703(21)45134, (01)04056869006703(21)145447, (01)04056869006703(21)45474, (01)04056869006703(21)145149, (01)04056869006703(21)45099, (01)04056869006703(21)45349, (01)04056869006703(21)46150, (01)04056869006703(21)145143, (01)04056869006703(21)46016, (01)04056869006703(21)145605, (01)04056869006703(21)146127, (01)04056869006703(21)145785, (01)04056869006703(21)45623, (01)04056869006703(21)145089, (01)04056869006703(21)145209, (01)04056869006703(21)45835, (01)04056869006703(21)145302, (01)04056869006703(21)145815, (01)04056869006703(21)45082, (01)04056869006703(21)45079, (01)04056869006703(21)45878, (01)04056869006703(21)45452, (01)04056869006703(21)145246, (01)04056869006703(21)46086, (01)04056869006703(21)45850, (01)04056869006703(21)46239, (01)04056869006703(21)46140, (01)04056869006703(21)45773, (01)04056869006703(21)145293, (01)04056869006703(21)145127, (01)04056869006703(21)45556, (01)04056869006703(21)45870, (01)04056869006703(21)145486, (01)04056869006703(21)46026, (01)04056869006703(21)145485, (01)04056869006703(21)145403, (01)04056869006703(21)145624, (01)04056869006703(21)145245, (01)04056869006703(21)46034, (01)04056869006703(21)45455, (01)04056869006703(21)145443, (01)04056869006703(21)145297, (01)04056869006703(21)45288, (01)04056869006703(21)145582, (01)04056869006703(21)145772, (01)04056869006703(21)46297, (01)04056869006703(21)45667, (01)04056869006703(21)45430, (01)04056869006703(21)146090, (01)04056869006703(21)45074, (01)04056869006703(21)45585, (01)04056869006703(21)45128, (01)04056869006703(21)45239, (01)04056869006703(21)145386, (01)04056869006703(21)145489, (01)04056869006703(21)45328, (01)04056869006703(21)45580, (01)04056869006703(21)45122, (01)04056869006703(21)45078, (01)04056869006703(21)145449, (01)04056869006703(21)45387, (01)04056869006703(21)45804, (01)04056869006703(21)145536, (01)04056869006703(21)145569, (01)04056869006703(21)145781, (01)04056869006703(21)145629, (01)04056869006703(21)145504, (01)04056869006703(21)45682, (01)04056869006703(21)45072, (01)04056869006703(21)145565, (01)04056869006703(21)46222, (01)04056869006703(21)45948, (01)04056869006703(21)145718, (01)04056869006703(21)145282, (01)04056869006703(21)45056, (01)04056869006703(21)45970, (01)04056869006703(21)45408, (01)04056869006703(21)145066, (01)04056869006703(21)145796, (01)04056869006703(21)46310, (01)04056869006703(21)46311, (01)04056869006703(21)45273, (01)04056869006703(21)45214, (01)04056869006703(21)45631, (01)04056869006703(21)45386, (01)04056869006703(21)145275, (01)04056869006703(21)145704, (01)04056869006703(21)45406, (01)04056869006703(21)46107, (01)04056869006703(21)46102, (01)04056869006703(21)45080, (01)04056869006703(21)145717, (01)04056869006703(21)145320, (01)04056869006703(21)45220, (01)04056869006703(21)45424, (01)04056869006703(21)145522, (01)04056869006703(21)145230, (01)04056869006703(21)45228, (01)04056869006703(21)45348, (01)04056869006703(21)45649, (01)04056869006703(21)46190, (01)04056869006703(21)145142, (01)04056869006703(21)145636, (01)04056869006703(21)145222, (01)04056869006703(21)145111, (01)04056869006703(21)145598, (01)04056869006703(21)45181, (01)04056869006703(21)45229, (01)04056869006703(21)45105, (01)04056869006703(21)145839, (01)04056869006703(21)45840, (01)04056869006703(21)45685, (01)04056869006703(21)145292, (01)04056869006703(21)45132, (01)04056869006703(21)46288, (01)04056869006703(21)45291, (01)04056869006703(21)45857, (01)04056869006703(21)46157, (01)04056869006703(21)45266, (01)04056869006703(21)45839, (01)04056869006703(21)45208, (01)04056869006703(21)146078, (01)04056869006703(21)145450, (01)04056869006703(21)45307, (01)04056869006703(21)45982, (01)04056869006703(21)46145, (01)04056869006703(21)46298, (01)04056869006703(21)145169, (01)04056869006703(21)45237, (01)04056869006703(21)45869, (01)04056869006703(21)45230, (01)04056869006703(21)45205, (01)04056869006703(21)45694, (01)04056869006703(21)45507, (01)04056869006703(21)46281, (01)04056869006703(21)145311, (01)04056869006703(21)45232, (01)04056869006703(21)145662, (01)04056869006703(21)45390, (01)04056869006703(21)145087, (01)04056869006703(21)45255, (01)04056869006703(21)145332, (01)04056869006703(21)45409, (01)04056869006703(21)45559, (01)04056869006703(21)45130, (01)04056869006703(21)146120, (01)04056869006703(21)145197, (01)04056869006703(21)45777, (01)04056869006703(21)145072, (01)04056869006703(21)145626, (01)04056869006703(21)145794, (01)04056869006703(21)145864, (01)04056869006703(21)146122, (01)04056869006703(21)146121, (01)04056869006703(21)45669, (01)04056869006703(21)45801, (01)04056869006703(21)45436, (01)04056869006703(21)45545, (01)04056869006703(21)46201, (01)04056869006703(21)46080, (01)04056869006703(21)45945, (01)04056869006703(21)145227, (01)04056869006703(21)45093, (01)04056869006703(21)46243, (01)04056869006703(21)45818, (01)04056869006703(21)45071, (01)04056869006703(21)45111, (01)04056869006703(21)145075, (01)04056869006703(21)46294, (01)04056869006703(21)45199, (01)04056869006703(21)45638, (01)04056869006703(21)45635, (01)04056869006703(21)46150, (01)04056869006703(21)145696, (01)04056869006703(21)46220, (01)04056869006703(21)45425, (01)04056869006703(21)45733, (01)04056869006703(21)45186, (01)04056869006703(21)46268, (01)04056869006703(21)45913. Serial Numbers: 45046, 45115, 45398, 145760, 145811, 45549, 45834, 146099, 146110, 45047, 146093, 46066, 45788, 146082, 45124, 45185, 45332, 45466, 145390, 45732, 45918, 45380, 46182, 45735, 45233, 145735, 145008, 145473, 145095, 145664, 45200, 146098, 146086, 45805, 45812, 45397, 46264, 45499, 45749, 45289, 46220, 45369, 45267, 45253, 45060, 146103, 45333, 146123, 46147, 145721, 145840, 145088, 146124, 45841, 45890, 46295, 45306, 45519, 145905, 46242, 145806, 46171, 45148, 45152, 46194, 145152, 45119, 46207, 145549, 45402, 145090, 145681, 45877, 45693, 45679, 146067, 45140, 46163, 145635, 46028, 45138, 46282, 45479, 45496, 45143, 45314, 45368, 46268, 45998, 145423, 145190, 145377, 46005, 45886, 45905, 145706, 145684, 45990, 145063, 146119, 46260, 45118, 145062, 45506, 145528, 145547, 46206, 145552, 45129, 145330, 45910, 145128, 145750, 45976, 145688, 45182, 145497, 45411, 145150, 45213, 145115, 45683, 145672, 145526, 45737, 45753, 145041, 145042, 45339, 45338, 145040, 145167, 45403, 145799, 145843, 145658, 145086, 45197, 45196, 145108, 46203, 145414, 46027, 145301, 45988, 45279, 145384, 145596, 45881, 145568, 45942, 146085, 145685, 145674, 45088, 145862, 45095, 45676, 46144, 45108, 145300, 46044, 46169, 45537, 145026, 46290, 145758, 45084, 145270, 146117, 146092, 45195, 145631, 45684, 45940, 146114, 145666, 145380, 145816, 45120, 145921, 145842, 145554, 46232, 45135, 145710, 145044, 145686, 46279, 145638, 145367, 145170, 145689, 145187, 45495, 45298, 145164, 46176, 45399, 46261, 145334, 145633, 45375, 45351, 146128, 45276, 46179, 145610, 46048, 145810, 46168, 46121, 45705, 45284, 145669, 145831, 145206, 145667, 45477, 145104, 45112, 146075, 145445, 46032, 145544, 46050, 45212, 46276, 145687, 145099, 145256, 46161, 46020, 45761, 145338, 45736, 145541, 145545, 145259, 145952, 46149, 45149, 45407, 45327, 45944, 45006, 45371, 46238, 145130, 45983, 46189, 145700, 45236, 45201, 145747, 46273, 45520, 145774, 46303, 45116, 145262, 145663, 45456, 45624, 145754, 45599, 145148, 45690, 45963, 45346, 45995, 45293, 145179, 45770, 145161, 145145, 145620, 145476, 46127, 45435, 45155, 46047, 45295, 45160, 45603, 145892, 45543, 45847, 145269, 145770, 46259, 45817, 145827, 45856, 45526, 145731, 145640, 145266, 45117, 45324, 45968, 145775, 45372, 145454, 45249, 45958, 145343, 145255, 145110, 46286, 145609, 145790, 145030, 145011, 145012, 145105, 45219, 145061, 145533, 145532, 45774, 45167, 45069, 146105, 145924, 145113, 45085, 45741, 45147, 145193, 46289, 145622, 45121, 45150, 46175, 45536, 46237, 145032, 46191, 46143, 45733, 46081, 45158, 45110, 145492, 46100, 45379, 45318, 145394, 45681, 145886, 145491, 45425, 145761, 45031, 145632, 145182, 145124, 45996, 45107, 45428, 45635, 46021, 46007, 46105, 46142, 45203, 45018, 145850, 146102, 146100, 45019, 145826, 145521, 145860, 45417, 45928, 145097, 145323, 46205, 145325, 45906, 146115, 45815, 45042, 145594, 145801, 45500, 45986, 45202, 45553, 45381, 145020, 45566, 145990, 145728, 45959, 46009, 45134, 145447, 45474, 145149, 45099, 45349, 46150, 145143, 46016, 145605, 146127, 145785, 45623, 145089, 145209, 45835, 145302, 145815, 45082, 45079, 45878, 45452, 145246, 46086, 45850, 46239, 46140, 45773, 145293, 145127, 45556, 45870, 145486, 46026, 145485, 145403, 145624, 145245, 46034, 45455, 145443, 145297, 45288, 145582, 145772, 46297, 45667, 45430, 146090, 45074, 45585, 45128, 45239, 145386, 145489, 45328, 45580, 45122, 45078, 145449, 45387, 45804, 145536, 145569, 145781, 145629, 145504, 45682, 45072, 145565, 46222, 45948, 145718, 145282, 45056, 45970, 45408, 145066, 145796, 46310, 46311, 45273, 45214, 45631, 45386, 145275, 145704, 45406, 46107, 46102, 45080, 145717, 145320, 45220, 45424, 145522, 145230, 45228, 45348, 45649, 46190, 145142, 145636, 145222, 145111, 145598, 45181, 45229, 45105, 145839, 45840, 45685, 145292, 45132, 46288, 45291, 45857, 46157, 45266, 45839, 45208, 146078, 145450, 45307, 45982, 46145, 46298, 145169, 45237, 45869, 45230, 45205, 45694, 45507, 46281, 145311, 45232, 145662, 45390, 145087, 45255, 145332, 45409, 45559, 45130, 146120, 145197, 45777, 145072, 145626, 145794, 145864, 146122, 146121, 45669, 45801, 45436, 45545, 46201, 46080, 45945, 145227, 45093, 46243, 45818, 45071, 45111, 145075, 46294, 45199, 45638. Additional serial numbers added 11/14/2025: 45395, 45442, 45291. Additional serial numbers added 01/23/2026: 45108, 45129. Additional serial numbers added 2/25/2026: 45635, 46150, 145696, 46220, 45425, 45733, 45186, 46268, 45913.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 8 of 15

MAGNETOM Skyra fit. Model Number: 10849580.

Z-2661-2025
Recall number
Z-2661-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10849580. UDI Numbers: (01)04056869006710(21)170068, (01)04056869006710(21)170053, (01)04056869006710(21)70022, (01)04056869006710(21)170049, (01)04056869006710(21)170018, (01)04056869006680(21)162078, (01)04056869006710(21)170109, (01)04056869006710(21)170039, (01)04056869006710(21)170066, (01)04056869006710(21)170023, (01)04056869006710(21)170030, (01)04056869006710(21)170004, (01)04056869006710(21)170016, (01)04056869006710(21)170077, (01)04056869006710(21)170058, (01)04056869006710(21)170002, (01)04056869006710(21)170050, (01)04056869006710(21)170010, (01)04056869006710(21)170019, (01)04056869006710(21)70026, (01)04056869006710(21)170056, (01)04056869006710(21)170061, (01)04056869006710(21)170105, (01)04056869006710(21)170017, (01)04056869006710(21)170041, (01)04056869006710(21)70032, (01)04056869006710(21)170111, (01)04056869006710(21)170048, (01)04056869006710(21)170101, (01)04056869006710(21)170100, (01)04056869006710(21)170060, (01)04056869006710(21)170099, (01)04056869006710(21)170036, (01)04056869006710(21)170007, (01)04056869006710(21)170001, (01)04056869006710(21)170009, (01)04056869006710(21)70020, (01)04056869006710(21)170112, (01)04056869006710(21)170113, (01)04056869006710(21)170054, (01)04056869006710(21)170047, (01)04056869006710(21)170046, (01)04056869006710(21)70023, (01)04056869006710(21)70027, (01)04056869006710(21)170110, (01)04056869006710(21)170095, (01)04056869006710(21)170075, (01)04056869006710(21)170011, (01)04056869006710(21)170081, (01)04056869006710(21)170044, (01)04056869006710(21)70028, (01)04056869006710(21)170043, (01)04056869006710(21)70031, (01)04056869006710(21)70008. Serial Numbers: 170068, 170053, 70022, 170049, 170018, 170106, 170109, 170039, 170066, 170023, 170030, 170004, 170016, 170077, 170058, 170002, 170050, 170010, 170019, 70026, 170056, 170061, 170105, 170017, 170041, 70032, 170111, 170048, 170101, 170100, 170060, 170099, 170036, 170007, 170001, 170009, 70020, 170112, 170113, 170054, 170047, 170046, 70023, 70027, 170110, 170095, 170075, 170011, 170081, 170044, 70028, 170043, 70031, 70008. Additional serial number added 2/25/2026: 170023. Additional serial Numbers Added 04/16/2026: 170013.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 9 of 15

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Z-2662-2025
Recall number
Z-2662-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11516217. UDI Numbers: (01)04056869299273(21)212087, (01)04056869299273(21)212098, (01)04056869299273(21)212088, (01)04056869299273(21)212068, (01)04056869299273(21)212081, (01)04056869299273(21)212018, (01)04056869299273(21)212041, (01)04056869299273(21)212038, (01)04056869299273(21)212047, (01)04056869299273(21)212019, (01)04056869299273(21)212037, (01)04056869299273(21)212032, (01)04056869299273(21)212049, (01)04056869299273(21)212017, (01)04056869299273(21)212064, (01)04056869299273(21)212096, (01)04056869299273(21)212065, (01)04056869299273(21)212016, (01)04056869299273(21)212023, (01)04056869299273(21)212056, (01)04056869299273(21)212054, (01)04056869299273(21)212063, (01)04056869299273(21)212051, (01)04056869299273(21)212055, (01)04056869299273(21)212021, (01)04056869299273(21)212060, (01)04056869299273(21)212011, (01)04056869299273(21)212066, (01)04056869299273(21)212074, (01)04056869299273(21)212090, (01)04056869299273(21)212034, (01)04056869299273(21)212029, (01)04056869299273(21)212097, (01)04056869299273(21)212099, (01)04056869299273(21)212039, (01)04056869299273(21)212059, (01)04056869299273(21)212030, (01)04056869299273(21)212035, (01)04056869299273(21)212036. Serial Numbers: 212087, 212098, 212088, 212068, 212081, 212018, 212041, 212038, 212047, 212019, 212037, 212032, 212049, 212017, 212064, 212096, 212065, 212016, 212023, 212056, 212054, 212063, 212051, 212055, 212021, 212060, 212011, 212066, 212074, 212090, 212034, 212029, 212097, 212099, 212039, 212059, 212030, 212035, 212036.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 10 of 15

MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

Z-2663-2025
Recall number
Z-2663-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

1. Model Number: 10837643. UDI Number: (01)04056869006802(21)72030. Serial Number: 72030. Additional serial number added 11/14/2025: 72023. 2. Model Number: 10655588. UDI Number: (01)04056869006796(21)56069. Serial Number: 56069.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 11 of 15

MAGNETOM Verio. Model Number: 10276755.

Z-2664-2025
Recall number
Z-2664-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
154 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10276755. UDI Numbers: N/A. Serial Numbers: 40649, 40585, 40781, 40243, 40408, 40628, 40848, 40870, 40783, 40473, 40240, 40497, 40564, 40425, 40778, 40389, 40340, 40523, 40582, 40168, 40291, 40283, 40201, 40850, 40331, 40126, 40744, 40821, 40433, 40502, 40179, 40246, 40273, 40766, 40753, 40828, 40737, 40352, 40313, 40382, 40670, 40387, 40631, 40669, 40131, 40541, 40466, 40292, 40375, 40161, 40745, 40268, 40284, 40325, 40799, 40190, 40877, 40104, 40195, 40407, 40640, 40797, 40254, 40142, 40665, 40622, 40264, 40420, 40633, 40150, 40514, 40727, 40710, 40328, 40156, 40800, 40692, 40165, 40441, 40864, 40482, 40472, 40859, 40220, 40858, 40779, 40346, 40295, 40233, 40629, 40681, 40464, 40568, 40200, 40663, 40334, 40277, 40276, 40879, 40222, 40361, 40553, 40378, 40714, 40715, 40252, 40250, 40423, 40204, 40486, 40251, 40488, 40109, 40855, 40429, 40232, 40157, 40440, 40259, 40545, 40556, 40687, 40140, 40237, 40399, 40312, 40235, 40697, 40684, 40398, 40871, 40700, 40368, 40656, 40606, 40163, 40278, 40562, 40671, 40526, 40658, 40644, 40376, 40686, 40713, 40775, 40863, 40326, 40409, 40116. Additional serial number added 11/14/2025: 40250. Additional serial number added 01/21/2026: 40459. Additional serial number added 2/25/2026: 40464. Additional serial number added 4/17/2026: 40711;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 12 of 15

MAGNETOM Verio Dot. Model Number: 10684333.

Z-2665-2025
Recall number
Z-2665-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10684333. UDI Numbers: (01)04056869006673(21)60060, (01)04056869006673(21)160040, (01)04056869006673(21)160028, (01)04056869006673(21)160021, (01)04056869006673(21)60108, (01)04056869006673(21)60121, (01)04056869006673(21)160019, (01)04056869006673(21)60091, (01)04056869006673(21)160020, (01)04056869006673(21)160043, (01)04056869006673(21)60062, (01)04056869006673(21)60061, (01)04056869006673(21)160029, (01)04056869006673(21)160038, (01)04056869006673(21)60086, (01)04056869006673(21)60126, (01)04056869006673(21)60047, (01)04056869006673(21)160036, (01)04056869006673(21)160003, (01)04056869006673(21)160042, (01)04056869006673(21)160024, (01)04056869006673(21)60092, (01)04056869006673(21)160035, (01)04056869006673(21)60102, (01)04056869006673(21)160039, (01)04056869006673(21)60112, (01)04056869006673(21)160030, (01)04056869006673(21)60099, (01)04056869006673(21)160007, (01)04056869006673(21)160001, (01)04056869006673(21)160006, (01)04056869006673(21)160009, (01)04056869006673(21)160033, (01)04056869006673(21)60053, (01)04056869006673(21)60070, (01)04056869006673(21)60101, (01)04056869006673(21)60125, (01)04056869006673(21)60085, (01)04056869006673(21)60113, (01)04056869006673(21)160027, (01)04056869006673(21)160012, (01)04056869006673(21)160016, (01)04056869006673(21)160032, (01)04056869006673(21)160013, (01)04056869006673(21)160014, (01)04056869006673(21)160018, (01)04056869006673(21)160031, (01)04056869006673(21)160011, (01)04056869006673(21)160015, (01)04056869006673(21)60054, (01)04056869006673(21)160037, (01)04056869006673(21)160034, (01)04056869006673(21)60063, (01)04056869006673(21)60079, (01)04056869006673(21)160008, (01)04056869006673(21)60110, (01)04056869006673(21)60124, (01)04056869006673(21)160041. Serial Numbers: 60060, 160040, 160028, 160021, 60108, 60121, 160019, 60091, 160020, 160043, 60062, 60061, 160029, 160038, 60086, 60126, 60047, 160036, 160003, 160042, 160024, 60092, 160035, 60102, 160039, 60112, 160030, 60099, 160007, 160001, 160006, 160009, 160033, 60053, 60070, 60101, 60125, 60085, 60113, 160027, 160012, 160016, 160032, 160013, 160014, 160018, 160031, 160011, 160015, 60054, 160037, 160034, 60063, 60079, 160008, 60110, 60124, 160041. Additional serial numbers added 2/25/2026: 60113.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 13 of 15

MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

Z-2666-2025
Recall number
Z-2666-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
78 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 10684334. UDI Numbers: (01)04056869006680(21)162012, (01)04056869006680(21)162055, (01)04056869006680(21)162039, (01)04056869006680(21)162002, (01)04056869006680(21)162014, (01)04056869006680(21)162069, (01)04056869006680(21)162083, (01)04056869006680(21)162075, (01)04056869006680(21)162028, (01)04056869006680(21)162060, (01)04056869006680(21)162035, (01)04056869006680(21)162038, (01)04056869006680(21)162016, (01)04056869006680(21)62040, (01)04056869006680(21)162036, (01)04056869006680(21)162079, (01)04056869006680(21)162054, (01)04056869006680(21)162088, (01)04056869006680(21)162071, (01)04056869006680(21)162078, (01)04056869006680(21)62032, (01)04056869006680(21)62037, (01)04056869006680(21)162077, (01)04056869006680(21)162042, (01)04056869006680(21)162025, (01)04056869006680(21)162082, (01)04056869006680(21)162085, (01)04056869006680(21)162026, (01)04056869006680(21)62027, (01)04056869006680(21)162040, (01)04056869006680(21)162032, (01)04056869006680(21)162072, (01)04056869006680(21)162037, (01)04056869006680(21)162043, (01)04056869006680(21)62014, (01)04056869006680(21)162047, (01)04056869006680(21)162023, (01)04056869006680(21)62019, (01)04056869006680(21)62050, (01)04056869006680(21)162089, (01)04056869006680(21)162061, (01)04056869006680(21)62018, (01)04056869006680(21)162004, (01)04056869006680(21)162080, (01)04056869006680(21)162013, (01)04056869006680(21)162007, (01)04056869006680(21)162049, (01)04056869006680(21)162031, (01)04056869006680(21)162009, (01)04056869006680(21)162008, (01)04056869006680(21)62029, (01)04056869006680(21)162056, (01)04056869006680(21)62025, (01)04056869006680(21)62022, (01)04056869006680(21)162048, (01)04056869006680(21)62036, (01)04056869006680(21)162087, (01)04056869006680(21)162081, (01)04056869006680(21)162073, (01)04056869006680(21)162044, (01)04056869006680(21)162076, (01)04056869006680(21)162003, (01)04056869006680(21)162006, (01)04056869006680(21)62023, (01)04056869006680(21)162021, (01)04056869006680(21)162074, (01)04056869006680(21)162017, (01)04056869006680(21)162029, (01)04056869006680(21)162022, (01)04056869006680(21)62035, (01)04056869006680(21)162065, (01)04056869006680(21)62039, (01)04056869006680(21)162034, (01)04056869006680(21)162001, (01)04056869006680(21)162018, (01)04056869006680(21)62042, (01)04056869006680(21)162086, (01)04056869006680(21)162011. Serial Numbers: 162012, 162055, 162039, 162002, 162014, 162069, 162083, 162075, 162028, 162060, 162035, 162038, 162016, 62040, 162036, 162079, 162054, 162088, 162071, 162078, 62032, 62037, 162077, 162042, 162025, 162082, 162085, 162026, 62027, 162040, 162032, 162072, 162037, 162043, 62014, 162047, 162023, 62019, 62050, 162089, 162061, 62018, 162004, 162080, 162013, 162007, 162049, 162031, 162009, 162008, 62029, 162056, 62025, 62022, 162048, 62036, 162087, 162081, 162073, 162044, 162076, 162003, 162006, 62023, 162021, 162074, 162017, 162029, 162022, 62035, 162065, 62039, 162034, 162001, 162018, 62042, 162086, 162011.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 14 of 15

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Z-2667-2025
Recall number
Z-2667-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
498 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11060815. UDI Numbers: (01)04056869039176(21)176636, (01)04056869039176(21)177211, (01)04056869039176(21)175728, (01)04056869039176(21)175685, (01)04056869039176(21)175851, (01)04056869039176(21)175768, (01)04056869039176(21)177298, (01)04056869039176(21)177295, (01)04056869039176(21)176756, (01)04056869039176(21)175754, (01)04056869039176(21)177349, (01)04056869039176(21)176757, (01)04056869039176(21)177232, (01)04056869039176(21)175935, (01)04056869039176(21)176967, (01)04056869039176(21)175741, (01)04056869039176(21)177052, (01)04056869039176(21)176060, (01)04056869039176(21)176371, (01)04056869039176(21)177012, (01)04056869039176(21)177146, (01)04056869039176(21)175770, (01)04056869039176(21)176375, (01)04056869039176(21)176122, (01)04056869039176(21)176308, (01)04056869039176(21)175669, (01)04056869039176(21)176212, (01)04056869039176(21)176755, (01)04056869039176(21)176781, (01)04056869039176(21)176302, (01)04056869039176(21)176036, (01)04056869039176(21)175766, (01)04056869039176(21)176825, (01)04056869039176(21)177151, (01)04056869039176(21)176087, (01)04056869039176(21)176771, (01)04056869039176(21)177299, (01)04056869039176(21)176451, (01)04056869039176(21)177352, (01)04056869039176(21)177354, (01)04056869039176(21)176779, (01)04056869039176(21)175870, (01)04056869039176(21)175838, (01)04056869039176(21)175692, (01)04056869039176(21)177359, (01)04056869039176(21)177119, (01)04056869039176(21)175977, (01)04056869039176(21)176037, (01)04056869039176(21)177244, (01)04056869039176(21)176686, (01)04056869039176(21)175831, (01)04056869039176(21)177096, (01)04056869039176(21)176660, (01)04056869039176(21)177034, (01)04056869039176(21)176639, (01)04056869039176(21)176397, (01)04056869039176(21)175805, (01)04056869039176(21)176358, (01)04056869039176(21)176293, (01)04056869039176(21)176118, (01)04056869039176(21)175681, (01)04056869039176(21)177088, (01)04056869039176(21)177035, (01)04056869039176(21)176093, (01)04056869039176(21)176189, (01)04056869039176(21)177337, (01)04056869039176(21)177333, (01)04056869039176(21)176094, (01)04056869039176(21)176736, (01)04056869039176(21)177105, (01)04056869039176(21)177007, (01)04056869039176(21)175787, (01)04056869039176(21)177381, (01)04056869039176(21)176027, (01)04056869039176(21)176340, (01)04056869039176(21)177144, (01)04056869039176(21)176258, (01)04056869039176(21)176363, (01)04056869039176(21)176561, (01)04056869039176(21)176665, (01)04056869039176(21)176577, (01)04056869039176(21)176572, (01)04056869039176(21)176559, (01)04056869039176(21)176696, (01)04056869039176(21)176452, (01)04056869039176(21)176081, (01)04056869039176(21)175853, (01)04056869039176(21)175893, (01)04056869039176(21)177033, (01)04056869039176(21)177392, (01)04056869039176(21)177116, (01)04056869039176(21)177124, (01)04056869039176(21)175897, (01)04056869039176(21)175883, (01)04056869039176(21)177329, (01)04056869039176(21)176567, (01)04056869039176(21)175640, (01)04056869039176(21)176033, (01)04056869039176(21)176316, (01)04056869039176(21)176529, (01)04056869039176(21)176219, (01)04056869039176(21)176254, (01)04056869039176(21)176865, (01)04056869039176(21)176709, (01)04056869039176(21)176059, (01)04056869039176(21)175829, (01)04056869039176(21)175706, (01)04056869039176(21)176635, (01)04056869039176(21)175903, (01)04056869039176(21)176374, (01)04056869039176(21)176217, (01)04056869039176(21)176832, (01)04056869039176(21)175834, (01)04056869039176(21)175655, (01)04056869039176(21)175660, (01)04056869039176(21)176630, (01)04056869039176(21)177258, (01)04056869039176(21)177162, (01)04056869039176(21)176661, (01)04056869039176(21)177371, (01)04056869039176(21)176829, (01)04056869039176(21)175907, (01)04056869039176(21)176956, (01)04056869039176(21)177213, (01)04056869039176(21)176570, (01)04056869039176(21)176532, (01)04056869039176(21)177257, (01)04056869039176(21)177262, (01)04056869039176(21)176319, (01)04056869039176(21)175850, (01)04056869039176(21)176332, (01)04056869039176(21)176096, (01)04056869039176(21)176492, (01)04056869039176(21)177265, (01)04056869039176(21)176654, (01)04056869039176(21)177332, (01)04056869039176(21)176092, (01)04056869039176(21)177356, (01)04056869039176(21)176288, (01)04056869039176(21)175765, (01)04056869039176(21)176350, (01)04056869039176(21)176751, (01)04056869039176(21)176038, (01)04056869039176(21)176437, (01)04056869039176(21)177319, (01)04056869039176(21)176086, (01)04056869039176(21)177347, (01)04056869039176(21)175976, (01)04056869039176(21)177125, (01)04056869039176(21)176391, (01)04056869039176(21)176828, (01)04056869039176(21)176814, (01)04056869039176(21)176030, (01)04056869039176(21)177086, (01)04056869039176(21)176813, (01)04056869039176(21)177118, (01)04056869039176(21)176433, (01)04056869039176(21)176594, (01)04056869039176(21)177159, (01)04056869039176(21)175825, (01)04056869039176(21)176414, (01)04056869039176(21)177178, (01)04056869039176(21)177238, (01)04056869039176(21)177123, (01)04056869039176(21)176962, (01)04056869039176(21)176211, (01)04056869039176(21)177102, (01)04056869039176(21)176843, (01)04056869039176(21)176102, (01)04056869039176(21)177366, (01)04056869039176(21)176000, (01)04056869039176(21)176483, (01)04056869039176(21)176048, (01)04056869039176(21)177209, (01)04056869039176(21)176906, (01)04056869039176(21)175734, (01)04056869039176(21)175964, (01)04056869039176(21)175682, (01)04056869039176(21)175650, (01)04056869039176(21)175651, (01)04056869039176(21)175625, (01)04056869039176(21)175656, (01)04056869039176(21)175875, (01)04056869039176(21)175843, (01)04056869039176(21)175721, (01)04056869039176(21)176002, (01)04056869039176(21)177324, (01)04056869039176(21)176831, (01)04056869039176(21)177402, (01)04056869039176(21)176459, (01)04056869039176(21)176658, (01)04056869039176(21)176101, (01)04056869039176(21)176203, (01)04056869039176(21)175676, (01)04056869039176(21)175866, (01)04056869039176(21)177309, (01)04056869039176(21)176084, (01)04056869039176(21)177312, (01)04056869039176(21)175695, (01)04056869039176(21)176130, (01)04056869039176(21)175661, (01)04056869039176(21)175920, (01)04056869039176(21)175737, (01)04056869039176(21)175847, (01)04056869039176(21)177289, (01)04056869039176(21)177283, (01)04056869039176(21)177293, (01)04056869039176(21)175819, (01)04056869039176(21)176948, (01)04056869039176(21)176637, (01)04056869039176(21)176176, (01)04056869039176(21)177143, (01)04056869039176(21)176519, (01)04056869039176(21)176733, (01)04056869039176(21)177214, (01)04056869039176(21)176607, (01)04056869039176(21)176238, (01)04056869039176(21)175849, (01)04056869039176(21)176261, (01)04056869039176(21)177346, (01)04056869039176(21)177345, (01)04056869039176(21)176667, (01)04056869039176(21)177210, (01)04056869039176(21)175979, (01)04056869039176(21)176328, (01)04056869039176(21)176333, (01)04056869039176(21)176336, (01)04056869039176(21)177237, (01)04056869039176(21)177136, (01)04056869039176(21)176811, (01)04056869039176(21)176312, (01)04056869039176(21)175915, (01)04056869039176(21)176537, (01)04056869039176(21)177398, (01)04056869039176(21)177149, (01)04056869039176(21)177216, (01)04056869039176(21)177217, (01)04056869039176(21)175700, (01)04056869039176(21)176137, (01)04056869039176(21)175639, (01)04056869039176(21)175922, (01)04056869039176(21)175873, (01)04056869039176(21)175774, (01)04056869039176(21)177276, (01)04056869039176(21)176186, (01)04056869039176(21)176573, (01)04056869039176(21)176069, (01)04056869039176(21)176341, (01)04056869039176(21)176449, (01)04056869039176(21)176420, (01)04056869039176(21)176677, (01)04056869039176(21)176874, (01)04056869039176(21)176969, (01)04056869039176(21)176652, (01)04056869039176(21)176927, (01)04056869039176(21)175740, (01)04056869039176(21)177339, (01)04056869039176(21)175912, (01)04056869039176(21)176168, (01)04056869039176(21)175982, (01)04056869039176(21)176508, (01)04056869039176(21)176091, (01)04056869039176(21)175701, (01)04056869039176(21)175624, (01)04056869039176(21)175671, (01)04056869039176(21)175673, (01)04056869039176(21)175672, (01)04056869039176(21)176011, (01)04056869039176(21)176139, (01)04056869039176(21)176010, (01)04056869039176(21)176259, (01)04056869039176(21)176877, (01)04056869039176(21)176880, (01)04056869039176(21)176876, (01)04056869039176(21)176159, (01)04056869039176(21)176683, (01)04056869039176(21)176526, (01)04056869039176(21)176958, (01)04056869039176(21)177203, (01)04056869039176(21)177383, (01)04056869039176(21)175616, (01)04056869039176(21)177155, (01)04056869039176(21)175954, (01)04056869039176(21)176676, (01)04056869039176(21)175914, (01)04056869039176(21)176544, (01)04056869039176(21)177104, (01)04056869039176(21)177234, (01)04056869039176(21)176393, (01)04056869039176(21)175803, (01)04056869039176(21)176287, (01)04056869039176(21)177160, (01)04056869039176(21)176299, (01)04056869039176(21)176788, (01)04056869039176(21)177331, (01)04056869039176(21)177253, (01)04056869039176(21)175615, (01)04056869039176(21)176239, (01)04056869039176(21)177170, (01)04056869039176(21)177336, (01)04056869039176(21)177334, (01)04056869039176(21)176732, (01)04056869039176(21)177303, (01)04056869039176(21)175716, (01)04056869039176(21)175876, (01)04056869039176(21)176004, (01)04056869039176(21)177184, (01)04056869039176(21)176218, (01)04056869039176(21)175634, (01)04056869039176(21)177181, (01)04056869039176(21)175990, (01)04056869039176(21)176405, (01)04056869039176(21)177150, (01)04056869039176(21)177072, (01)04056869039176(21)176524, (01)04056869039176(21)177361, (01)04056869039176(21)176119, (01)04056869039176(21)176586, (01)04056869039176(21)177374, (01)04056869039176(21)176326, (01)04056869039176(21)176868, (01)04056869039176(21)176475, (01)04056869039176(21)175830, (01)04056869039176(21)175611, (01)04056869039176(21)175820, (01)04056869039176(21)177259, (01)04056869039176(21)176169, (01)04056869039176(21)177205, (01)04056869039176(21)177286, (01)04056869039176(21)176546, (01)04056869039176(21)176550, (01)04056869039176(21)175810, (01)04056869039176(21)177384, (01)04056869039176(21)176354, (01)04056869039176(21)176246, (01)04056869039176(21)176204, (01)04056869039176(21)176465, (01)04056869039176(21)177109, (01)04056869039176(21)176021, (01)04056869039176(21)175633, (01)04056869039176(21)176020, (01)04056869039176(21)177061, (01)04056869039176(21)176127, (01)04056869039176(21)176888, (01)04056869039176(21)176596, (01)04056869039176(21)177318, (01)04056869039176(21)175761, (01)04056869039176(21)176146, (01)04056869039176(21)177031, (01)04056869039176(21)176184, (01)04056869039176(21)177397, (01)04056869039176(21)176348, (01)04056869039176(21)176251, (01)04056869039176(21)176691, (01)04056869039176(21)175731, (01)04056869039176(21)177348, (01)04056869039176(21)177011, (01)04056869039176(21)176533, (01)04056869039176(21)176555, (01)04056869039176(21)177107, (01)04056869039176(21)175760, (01)04056869039176(21)176120, (01)04056869039176(21)176083, (01)04056869039176(21)176229, (01)04056869039176(21)177363, (01)04056869039176(21)175869, (01)04056869039176(21)177292, (01)04056869039176(21)177172, (01)04056869039176(21)177173, (01)04056869039176(21)176731, (01)04056869039176(21)176194, (01)04056869039176(21)176248, (01)04056869039176(21)175839, (01)04056869039176(21)175986, (01)04056869039176(21)175663, (01)04056869039176(21)176161, (01)04056869039176(21)176939, (01)04056869039176(21)176700, (01)04056869039176(21)176271, (01)04056869039176(21)176930, (01)04056869039176(21)177279, (01)04056869039176(21)176563, (01)04056869039176(21)176837, (01)04056869039176(21)176849, (01)04056869039176(21)177368, (01)04056869039176(21)177380, (01)04056869039176(21)176790, (01)04056869039176(21)176054, (01)04056869039176(21)176445, (01)04056869039176(21)175872, (01)04056869039176(21)175777, (01)04056869039176(21)176560, (01)04056869039176(21)177133, (01)04056869039176(21)176651, (01)04056869039176(21)176377, (01)04056869039176(21)176376, (01)04056869039176(21)176196, (01)04056869039176(21)176195, (01)04056869039176(21)175647, (01)04056869039176(21)175807, (01)04056869039176(21)175627, (01)04056869039176(21)175629, (01)04056869039176(21)176068, (01)04056869039176(21)176064, (01)04056869039176(21)175816, (01)04056869039176(21)175814, (01)04056869039176(21)177275, (01)04056869039176(21)177273, (01)04056869039176(21)176450, (01)04056869039176(21)176578, (01)04056869039176(21)175772, (01)04056869039176(21)175779, (01)04056869039176(21)177278, (01)04056869039176(21)177270, (01)04056869039176(21)177267, (01)04056869039176(21)177281, (01)04056869039176(21)176053, (01)04056869039176(21)177239, (01)04056869039176(21)176953, (01)04056869039176(21)175786, (01)04056869039176(21)176815, (01)04056869039176(21)175894, (01)04056869039176(21)176735, (01)04056869039176(21)176994, (01)04056869039176(21)177055, (01)04056869039176(21)175993, (01)04056869039176(21)176057, (01)04056869039176(21)175775, (01)04056869039176(21)177032, (01)04056869039176(21)176512, (01)04056869039176(21)175691, (01)04056869039176(21)176545, (01)04056869039176(21)177220, (01)04056869039176(21)177037, (01)04056869039176(21)177285, (01)04056869039176(21)176944, (01)04056869039176(21)176047, (01)04056869039176(21)177145, (01)04056869039176(21)175965, (01)04056869039176(21)175635, (01)04056869039176(21)175746, (01)04056869039176(21)176072, (01)04056869039176(21)175654, (01)04056869039176(21)176294, (01)04056869039176(21)176089, (01)04056869039176(21)176085, (01)04056869039176(21)176522, (01)04056869039176(21)177189, (01)04056869039176(21)175689, (01)04056869039176(21)177338, (01)04056869039176(21)176178, (01)04056869039176(21)176541, (01)04056869039176(21)176759, (01)04056869039176(21)176142, (01)04056869039176(21)175919, (01)04056869039176(21)177098, (01)04056869039176(21)176202, (01)04056869039176(21)176689, (01)04056869039176(21)177280, (01)04056869039176(21)177229, (01)04056869039176(21)176548, (01)04056869039176(21)177230, (01)04056869039176(21)177231, (01)04056869039176(21)176852, (01)04056869039176(21)176502, (01)04056869039176(21)176282, (01)04056869039176(21)175881, (01)04056869039176(21)176912, (01)04056869039176(21)176058, (01)04056869039176(21)175738, (01)04056869039176(21)175657, (01)04056869039176(21)175705, (01)04056869039176(21)175758, (01)04056869039176(21)177054, (01)04056869039176(21)177386, (01)04056869039176(21)176754, (01)04056869039176(21)176925, (01)04056869039176(21)177255, (01)04056869039176(21)176457, (01)04056869039176(21)177256, (01)04056869039176(21)177127, (01)04056869039176(21)175614, (01)04056869039176(21)177164, (01)04056869039176(21)176486, (01)04056869039176(21)176438, (01)04056869039176(21)176157, (01)04056869039176(21)176995, (01)04056869039176(21)177323, (01)04056869039176(21)176410, (01)04056869039176(21)176680, (01)04056869039176(21)176518, (01)04056869039176(21)175941, (01)04056869039176(21)175618, (01)04056869039176(21)176364, (01)04056869039176(21)175801, (01)04056869039176(21)175822, (01)04056869039176(21)176040, (01)04056869039176(21)175643. Serial Numbers: 176636, 177211, 175728, 175685, 175851, 175768, 177298, 177295, 176756, 175754, 177349, 176757, 177232, 175935, 176967, 175741, 177052, 176060, 176371, 177012, 177146, 175770, 176375, 176122, 176308, 175669, 176212, 176755, 176781, 176302, 176036, 175766, 176825, 177151, 176087, 176771, 177299, 176451, 177352, 177354, 176779, 175870, 175838, 175692, 177359, 177119, 175977, 176037, 177244, 176686, 175831, 177096, 176660, 177034, 176639, 176397, 175805, 176358, 176293, 176118, 175681, 177088, 177035, 176093, 176189, 177337, 177333, 176094, 176736, 177105, 177007, 175787, 177381, 176027, 176340, 177144, 176258, 176363, 176561, 176665, 176577, 176572, 176559, 176696, 176452, 176081, 175853, 175893, 177033, 177392, 177116, 177124, 175897, 175883, 177329, 176567, 175640, 176033, 176316, 176529, 176219, 176254, 176865, 176709, 176059, 175829, 175706, 176635, 175903, 176374, 176217, 176832, 175834, 175655, 175660, 176630, 177258, 177162, 176661, 177371, 176829, 175907, 176956, 177213, 176570, 176532, 177257, 177262, 176319, 175850, 176332, 176096, 176492, 177265, 176654, 177332, 176092, 177356, 176288, 175765, 176350, 176751, 176038, 176437, 177319, 176086, 177347, 175976, 177125, 176391, 176828, 176814, 176030, 177086, 176813, 177118, 176433, 176594, 177159, 175825, 176414, 177178, 177238, 177123, 176962, 176211, 177102, 176843, 176102, 177366, 176000, 176483, 176048, 177209, 176906, 175734, 175964, 175682, 175650, 175651, 175625, 175656, 175875, 175843, 175721, 176002, 177324, 176831, 177402, 176459, 176658, 176101, 176203, 175676, 175866, 177309, 176084, 177312, 175695, 176130, 175661, 175920, 175737, 175847, 177289, 177283, 177293, 175819, 176948, 176637, 176176, 177143, 176519, 176733, 177214, 176607, 176238, 175849, 176261, 177346, 177345, 176667, 177210, 175979, 176328, 176333, 176336, 177237, 177136, 176811, 176312, 175915, 176537, 177398, 177149, 177216, 177217, 175700, 176137, 175639, 175922, 175873, 175774, 177276, 176186, 176573, 176069, 176341, 176449, 176420, 176677, 176874, 176969, 176652, 176927, 175740, 177339, 175912, 176168, 175982, 176508, 176091, 175701, 175624, 175671, 175673, 175672, 176011, 176139, 176010, 176259, 176877, 176880, 176876, 176159, 176683, 176526, 176958, 177203, 177383, 175616, 177155, 175954, 176676, 175914, 176544, 177104, 177234, 176393, 175803, 176287, 177160, 176299, 176788, 177331, 177253, 175615, 176239, 177170, 177336, 177334, 176732, 177303, 175716, 175876, 176004, 177184, 176218, 175634, 177181, 175990, 176405, 177150, 177072, 176524, 177361, 176119, 176586, 177374, 176326, 176868, 176475, 175830, 175611, 175820, 177259, 176169, 177205, 177286, 176546, 176550, 175810, 177384, 176354, 176246, 176204, 176465, 177109, 176021, 175633, 176020, 177061, 176127, 176888, 176596, 177318, 175761, 176146, 177031, 176184, 177397, 176348, 176251, 176691, 175731, 177348, 177011, 176533, 176555, 177107, 175760, 176120, 176083, 176229, 177363, 175869, 177292, 177172, 177173, 176731, 176194, 176248, 175839, 175986, 175663, 176161, 176939, 176700, 176271, 176930, 177279, 176563, 176837, 176849, 177368, 177380, 176790, 176054, 176445, 175872, 175777, 176560, 177133, 176651, 176377, 176376, 176196, 176195, 175647, 175807, 175627, 175629, 176068, 176064, 175816, 175814, 177275, 177273, 176450, 176578, 175772, 175779, 177278, 177270, 177267, 177281, 176053, 177239, 176953, 175786, 176815, 175894, 176735, 176994, 177055, 175993, 176057, 175775, 177032, 176512, 175691, 176545, 177220, 177037, 177285, 176944, 176047, 177145, 175965, 175635, 175746, 176072, 175654, 176294, 176089, 176085, 176522, 177189, 175689, 177338, 176178, 176541, 176759, 176142, 175919, 177098, 176202, 176689, 177280, 177229, 176548, 177230, 177231, 176852, 176502, 176282, 175881, 176912, 176058, 175738, 175657, 175705, 175758, 177054, 177386, 176754, 176925, 177255, 176457, 177256, 177127, 175614, 177164, 176486, 176438, 176157, 176995, 177323, 176410, 176680, 176518, 175941, 175618, 176364, 175801, 175822, 176040, 175643.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

device · product 15 of 15

MAGNETOM Vida Fit. Model Number: 11410481.

Z-2668-2025
Recall number
Z-2668-2025
Initiated
August 28, 2025
Classification
Class I
Status
Ongoing
Quantity
41 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Code information

Model Number: 11410481. UDI Numbers: (01)04056869245188(21)202129, (01)04056869245188(21)202025, (01)04056869245188(21)202139, (01)04056869245188(21)202016, (01)04056869245188(21)202051, (01)04056869245188(21)202055, (01)04056869245188(21)202114, (01)04056869245188(21)202119, (01)04056869245188(21)202013, (01)04056869245188(21)202050, (01)04056869245188(21)202102, (01)04056869245188(21)202160, (01)04056869245188(21)202127, (01)04056869245188(21)202071, (01)04056869245188(21)202078, (01)04056869245188(21)202123, (01)04056869245188(21)202082, (01)04056869245188(21)202107, (01)04056869245188(21)202031, (01)04056869245188(21)202110, (01)04056869245188(21)202108, (01)04056869245188(21)202101, (01)04056869245188(21)202093, (01)04056869245188(21)202104, (01)04056869245188(21)202028, (01)04056869245188(21)202026, (01)04056869245188(21)202076, (01)04056869245188(21)202142, (01)04056869245188(21)202125, (01)04056869245188(21)202155, (01)04056869245188(21)202084, (01)04056869245188(21)202151, (01)04056869245188(21)202068, (01)04056869245188(21)202135, (01)04056869245188(21)202121, (01)04056869245188(21)202006, (01)04056869245188(21)202010, (01)04056869245188(21)202011, (01)04056869245188(21)202146, (01)04056869245188(21)202145. Serial Numbers: 202129, 202025, 202139, 202016, 202051, 202055, 202114, 202119, 202013, 202050, 202102, 202160, 202127, 202071, 202078, 202123, 202082, 202107, 202031, 202110, 202108, 202101, 202093, 202104, 202028, 202026, 202076, 202142, 202125, 202155, 202084, 202151, 202068, 202135, 202121, 202006, 202010, 202011, 202146, 202145. Additional serial number added on 01/23/2026: 202135

Distribution pattern

Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa.

Field note

Send feedback

We'll only use this to respond to your feedback.