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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72684

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

Open FDA event record

Event summary

Timeline bucket
October 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) 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

6 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 6

Brilliance 64 Computed Tomography X-ray system

Z-0544-2016
Recall number
Z-0544-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728231; S/N: 4001, 9074, 9099, 9538, 9549, 9573, 9638, 9646, 9656, 9667, 9703, 9738, 9755, 9782, 9811, 9822, 9909, 9923, 9927, 9933, 10021, 10042, 10077, 10150, 10180, 10379, 29056, 29107, 29115, 90124, 90154, 95024, 95130, 95222, 95236, 95258, 95261, 95364, 95399, 95410, 95475, 95551, 95614, 95668, 95688 & 95691.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 2 of 6

Brilliance iCT Computed Tomography X-ray system

Z-0545-2016
Recall number
Z-0545-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
51 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647, 100651, 100654, 100655, 100659, 100660, 100662, 100667 & 100669.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 3 of 6

Brilliance iCT SP Computed Tomography X-ray system

Z-0546-2016
Recall number
Z-0546-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
12 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728311; S/N: 200047, 200051, 200067, 200074, 200098, 200127, 200200, 200202, 200203, 200204, 200206 & 200209.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 4 of 6

Ingenuity Core Computed Tomography X-ray system

Z-0547-2016
Recall number
Z-0547-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
135 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728321; S/N: 52007, 52008, 52010, 52013, 52014, 52015, 52018, 52019, 52020, 52021, 52024, 52027, 52032, 52033, 52034, 52035, 52036, 52037, 52038, 52040, 52041, 52042, 52045, 52046, 52047, 52048, 52051, 52053, 52055, 52057, 52058, 52060, 52064, 52065, 52067, 52068, 52069, 52070, 52075, 52078, 310017, 310026, 310039, 310042, 310052, 310055, 310059, 310064, 310069, 310071, 310081, 310088, 310098, 310111, 310113, 310119, 310121, 310133, 310143, 310144, 310149, 310151, 310157, 310159, 310160, 310204, 310205, 310206, 310208, 310209, 310210, 310211, 310212, 310213, 310215, 310216, 310217, 310219, 310220, 310223, 310224, 310225, 310226, 310228, 310231, 333002, 333009, 333014, 333015, 333030, 333031, 333037, 333042, 333043, 333044, 333046, 333048, 333049, 333050, 333052, 333053, 333054, 333055, 333056, 333058, 333059, 333060, 333061, 333062, 333063, 333065, 333066, 333067, 333069, 333070, 333072, 333073, 333074, 333075, 333076, 333077, 333078, 333079, 333080, 333081, 333082, 333086, 333087, 333090, 333091, 333093, 333101, 333110 & 333112.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 5 of 6

Ingenuity Core 128 Computed Tomography X-ray system

Z-0548-2016
Recall number
Z-0548-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
177 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728323; S/N: 30016, 32012, 32013, 32016, 32024, 32028, 32033, 32036, 32041, 32046, 32048, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32058, 32059, 32062, 32063, 32064, 32068, 32069, 32070, 32072, 32073, 32074, 32075, 32077, 32078, 32079, 32081, 32082, 32083, 32084, 32086, 32087, 32089, 32092, 32093, 32095, 32097, 32098, 32099, 32100, 32102, 32103, 32104, 32105, 32106, 32108, 32110, 32113, 32114, 32115, 32116, 32119, 32120, 32122, 32123, 32124, 32125, 32128, 32129, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32140, 32141, 32145, 32146, 320003, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320054, 320058, 320069, 320073, 320078, 320079, 320090, 320092, 320099, 320114, 320115, 320123, 320125, 320126, 320128, 320133, 320134, 320138, 320146, 320200, 320201, 320202, 320203, 320204, 320205, 320208, 320212, 320217, 320219, 320220, 320222, 320223, 320224, 320225, 320226, 320228, 320231, 320232, 320239, 320241, 320243, 320246, 320247, 336013, 336015, 336016, 336018, 336027, 336029, 336034, 336046, 336059, 336060, 336064, 336066, 336068, 336071, 336072, 336073, 336075, 336078, 336079, 336080, 336081, 336083, 336084, 336085, 336086, 336087, 336088, 336089, 336091, 336092, 336095, 336097, 336098, 336099, 336105, 336107, 336108, 336110, 336111, 336112, 336113, 336115, 336116, 336117, 336119, 336120, 336121, 336122, 336123, 336126, 336128, 336131, 336132, 336133, 336135, 336137, 336138, 336139, 336140, 336143, 336144, 336145, 336147, 336148, 336150 & 336151.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 6 of 6

Ingenuity CT Computed Tomography X-ray system

Z-0549-2016
Recall number
Z-0549-2016
Initiated
October 29, 2015
Classification
Class II
Status
Terminated
Quantity
31 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software (versions preceding 4.1.2) without buying the helical perfusion license key could

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

Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

Code information

Model No. 728326; S/N: 2, 1234, 30005, 30009, 30017, 30018, 30020, 30023, 30028, 30031, 30034, 30037, 31001, 32065, 32067, 52030, 52031, 52044, 52049, 52050, 300159, 300204, 300205, 300207, 300208, 300209, 310002, 310003, 333057, 333064 & 336061.

Distribution pattern

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

Field note

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