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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77377

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

Open FDA event record

Event summary

Timeline bucket
May 19, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

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

16 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 16

GE Healthcare Revolution EVO X-ray system

Z-2181-2017
Recall number
Z-2181-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 2 of 16

GE Healthcare Optima CT660, CT680 X-ray system

Z-2182-2017
Recall number
Z-2182-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 3 of 16

GE Healthcare LightSpeed VCT X-ray system

Z-2183-2017
Recall number
Z-2183-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 4 of 16

GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system

Z-2184-2017
Recall number
Z-2184-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 5 of 16

GE Healthcare Optima CT520 X-ray system

Z-2185-2017
Recall number
Z-2185-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 6 of 16

GE Healthcare Optima CT540 X-ray system

Z-2186-2017
Recall number
Z-2186-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 7 of 16

GE Healthcare lnnova IGS 540 ACT X-ray system

Z-2187-2017
Recall number
Z-2187-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 8 of 16

GE Healthcare BrightSpeed X-ray system

Z-2188-2017
Recall number
Z-2188-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 9 of 16

GE Healthcare Lightspeed RT16 X-ray system

Z-2189-2017
Recall number
Z-2189-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 10 of 16

GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system

Z-2190-2017
Recall number
Z-2190-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 11 of 16

GE Healthcare Discovery Ml DR X-ray system

Z-2191-2017
Recall number
Z-2191-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 12 of 16

GE Healthcare Discovery IQ X-ray system

Z-2192-2017
Recall number
Z-2192-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 13 of 16

GE Healthcare Discovery Ml X-ray system

Z-2193-2017
Recall number
Z-2193-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 14 of 16

GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

Z-2194-2017
Recall number
Z-2194-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 15 of 16

GE Healthcare Discovery NM/CT 670 CZT X-ray system

Z-2195-2017
Recall number
Z-2195-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

device · product 16 of 16

GE Healthcare Discovery NM/CT 570c X-ray system

Z-2196-2017
Recall number
Z-2196-2017
Initiated
May 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
10,884

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

Code information

n/a

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

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