Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79666

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

Open FDA event record

Event summary

Timeline bucket
February 08, 2018
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

12 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 12

Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1404-2018
Recall number
Z-1404-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
151

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No. : 345247 345268 345206 345248 345208 345244 345253 345257 345279 345054 345059 345067 345066 345069 345068 345085 345100 345099 345048 345047 345049 345050 345052 345051 345053 345055 345056 345057 345058 345076 345062 345060 345061 345063 345065 345064 345074 345070 345072 345071 345073 345077 345075 345078 345079 345080 345081 345082 345116 345083 345084 345086 345087 345088 345091 345092 345094 345093 345095 345096 345098 345097 345102 345101 345103 345105 345106 345104 345107 345118 345111 345108 345109 345112 345113 345114 345115 345118 345117 345119 345120 345275 345202 345210 345249 345252 345263 345266 345246 345201 345226 345211 345207 345211 345214 345215 345216 345217 345219 345224 345223 345225 345227 345230 345229 345234 345236 345242 345240 345243 345245 345251 345256 345232 345258 345261 345265 345274 345273 345272 345278 345220 345255 345205 345209 345213 345212 345221 345222 345233 345235 345239 345238 345259 345260 345231 345241 345204 345276 345277 345269 345203 345228 345250 345262 345267 345270 345228 345237 345271 345202

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 2 of 12

Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1405-2018
Recall number
Z-1405-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
172

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No. : 32045 52062 30003 30004 300225 30029 30007 300220 300211 300229 300243 300209 30027 30041 30040 300247 300233 300237 300236 30038 300222 300227 300234 30038 30037 30039 30048 300240 30046 30044 30036 300215 300201 300200 336121 300202 300228 300248 30011 300214 300217 300216 300224 300242 300245 300231 300230 300226 300239 300241 30028 30042 30018 30019 30018 300238 30030 336084 333057 30043 30033 30033 30026 32109 32102 30045 300221 30017 52060 30034 30049 30047 320392 320383 310328 310313 300204 300207 300205 300203 300150 300212 300213 300206 320205 300208 300210 300219 300086 300235 300223 300232 310314 310377 336286 320247 310362 310375 338003 320434 320388 320385 320322 320396 320368 320338 320364 320346 320369 320400 320437 336147 320214 320235 320378 320297 320337 320395 310353 320339 320402 320397 310379 310370 32128 320353 320405 320401 320375 310387 310326 310340 310339 320404 310356 320382 310342 310341 320406 320409 310360 310357 310349 320426 310135 310211 310302 310328 310351 320349 310358 310352 310355 310348 310381 320389 310369 310361 310313 320372 320347 320328 320341 310333 320298 310354 320324 320354 320361 310359 333181 300218

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 3 of 12

Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1406-2018
Recall number
Z-1406-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
281

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No. : 310204 310216 310264 52004 333094 52084 333060 333076 52069 333103 333110 333112 333064 52066 333142 310231 333096 333149 52053 333061 333062 333136 310383 52077 333093 310219 52065 310226 333092 333107 333108 310222 310206 310207 310225 310219 310226 310238 310317 310324 310330 310365 310337 310224 333072 333067 333074 333070 52065 333086 333085 333078 333079 333156 52075 52078 333088 33084 333083 333089 52083 333099 333098 333104 333101 52079 333106 333111 52082 333113 333123 333122 333121 333118 333124 333127 333125 333141 333147 333134 333137 333139 333155 333164 52052 333097 52014 333090 333132 333159 333073 52070 333080 333081 333087 333071 333126 333120 333140 333145 333146 333150 333151 333154 333082 52012 333056 333095 333117 310209 310245 333091 333109 333115 333105 333129 333138 333144 310214 52067 310318 52068 333066 333075 333131 333133 333163 52080 333114 333116 52081 52061 310239 310233 310366 310380 52056 52059 52063 52072 52071 52076 52064 333063 333068 333148 333152 333130 333059 333077 310347 333065 333119 52057 52058 52055 333102 333143 333153 310207 333100 333135 52054 310203 310299 310278 310277 310220 310319 310208 310213 310212 310217 310215 310274 310253 310267 310262 310241 310228 310258 310285 310249 310255 310294 310266 310243 310235 310363 310256 310289 310254 310292 310290 310283 310281 310301 310261 310271 310296 310227 310234 310259 310242 310286 310280 310232 310316 310287 310270 310273 310304 310282 310246 310269 310297 310303 310250 310295 310272 310260 310237 310221 310247 310229 310311 310305 310307 310308 310310 310309 310331 310322 310321 310364 310329 310335 310346 310334 310345 310350 310336 310344 310367 310279 310244 310298 310306 310275 310276 310284 310291 310288 310293 333071 310205 310210 310218 310300 310223 310265 310230 310236 310248 310257 310252 310240 310268 310263 310327 310251 310338 310343 310332 310016 310323 333079 310225 333078 336084 310315

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 4 of 12

Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1407-2018
Recall number
Z-1407-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
591

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 320309 336076 32104 336092 336150 336100 336228 336089 336095 336100 336116 32125 32123 336117 336120 336126 336139 336131 336149 336142 336150 336152 336161 336166 336150 336182 336203 336211 336217 336220 336221 336289 336283 336133 336145 336191 30035 345218 52073 336213 320227 320419 336188 32106 336123 336216 32117 32119 32151 66769829 320265 32144 32150 32160 32157 32159 32127 320363 32145 32129 32141 32133 32127 32168 336737 336760 336764 336766 336807 336809 320260 320268 320270 320271 320253 320276 320280 320285 320289 320291 320292 320318 320294 320316 320259 320279 320286 320326 320293 320327 320296 320290 320306 320321 320307 320311 320319 320315 320366 320390 320379 320371 320386 320323 320325 320340 320334 320329 320331 320391 320359 320384 320343 320365 320403 320374 320380 320393 320420 336800 32108 32096 32122 336802 32115 336803 32116 32114 32118 32121 32120 32126 32130 32131 32097 32129 32132 32133 32137 32134 32135 32136 32138 32142 32149 32154 32143 32145 32141 32140 336733 336734 32146 32147 32152 32161 32153 336735 32169 32148 336736 32156 32158 336738 32155 32160 336739 336740 336741 336742 32091 336743 336744 32165 336745 32163 336748 336746 32164 336747 32166 32167 32180 336749 336730 336776 336752 336777 32171 32173 336753 336754 32172 336757 336759 336756 336755 336758 336761 336762 336763 336765 336767 336768 336769 336772 336770 336756 336773 336775 336774 336779 336783 336785 336787 336786 336788 336789 336791 336793 336790 336795 336794 336799 336792 336801 336798 336796 336797 336805 336806 336808 336167 336266 32111 336104 336169 336261 32042 32111 336207 336179 336180 336267 336012 336115 3202694 320235 32179 32170 320201 320200 320220 320206 320221 320222 320262 320231 320237 320236 320254 320269 320245 320417 320275 320281 320303 320301 320288 320302 320370 320310 320313 320317 320344 320412 320367 320444 320381 320399 320411 320438 320429 320424 320358 320212 336096 320229 320266 336205 32103 336083 336115 336151 336125 32124 336147 336174 336196 336197 336212 336208 336242 336235 336253 336244 336257 336250 336265 336291 336270 336272 336288 336165 336101 336138 336151 336132 336189 336190 336215 336249 336277 320348 30025 32100 336068 32047 336128 336163 336144 32101 336246 32128 336129 336103 336067 336070 336071 336069 32101 336028 336144 336118 336112 336109 336130 336141 336286 336184 336183 336222 320239 336223 320239 336292 320335 336172 336206 336225 336227 336260 336263 336273 320099 32049 336136 336209 336153 336193 336195 336177 336285 320204 32174 336088 336106 32112 336134 336111 336119 336198 336122 336136 336137 336135 336140 336146 336155 336156 336159 336162 336181 336187 336251 336210 336214 336224 336230 336232 336243 336252 336262 336264 336287 336127 32181 336157 336218 336239 336256 336268 336282 32018 336093 336046 320342 336199 336086 336110 336108 336204 336091 336171 320238 320278 320304 320376 320432 320428 320352 336154 336160 336284 320351 320351 320215 336233 336173 336236 336170 320336 336102 32057 336219 336231 336226 32105 336085 32110 336158 320230 336168 320230 320410 336176 336087 336094 336098 336097 336124 336186 336238 336240 336255 336269 336113 32055 320237 320229 320236 336259 336237 336202 336194 336114 320355 32113 336234 336241 336258 336271 336254 336090 336105 336107 336164 336192 336175 336200 336201 336274 336247 336245 336248 336275 336276 336278 336290 336293 336279 336229 336178 32139 320228 320203 320202 320208 320219 320226 320223 320242 320284 320243 320282 320240 320257 320252 320272 320273 320274 320300 320345 320416 320377 320305 320207 320232 320216 320217 320209 320258 320356 320256 320261 320267 320312 320314 320320 320373 320360 320210 320213 320225 320218 320224 320233 320241 320234 320250 320263 320251 320277 320248 320255 320283 320295 320299 320362 320287 320357 320308 320350 320387 320392 320383 320332 336125 336185 336152 32147 32146 320229 32110 336751 336771 336815 336810 336812 336811 336813 336814 336819 336817 336816 336818 336820 336823 336821 336822 336824

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 5 of 12

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1408-2018
Recall number
Z-1408-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
295

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No: 100410 100608 100611 100413 85071 100816 100667 85031 100654 100667 100604 100703 85031 85054 100672 100638 100616 100619 85078 100669 85048 85060 85062 100666 85058 85082 100304 85067 85063 100704 100769 100722 100600 100628 100771 100621 100627 100738 100615 100602 100617 100635 100624 100636 100696 100639 100651 100643 100642 100659 100640 100644 100669 100734 100662 100706 100716 100691 100711 100727 100683 100760 100677 100709 100692 100717 100678 100697 100687 100733 100732 100799 100736 100740 100778 100749 100809 100751 100762 100755 100746 100766 100763 100757 100765 100773 100783 100772 100775 100797 100780 100784 100787 100798 100786 100768 100612 100614 100622 100637 100656 100710 100666 100735 100680 100713 100707 100701 100698 100712 100785 100726 100776 100792 100745 100737 100767 100758 100781 100750 100814 100807 85015 85016 85026 85023 85022 85021 85081 85020 85044 85036 85037 85027 85045 85028 85047 85041 85040 85030 85048 85052 85051 85057 85053 85059 85055 85060 85062 85064 85065 85066 85075 85069 85068 85070 100310 85035 85042 85046 85063 85067 85072 85061 100730 100770 85032 100623 100646 100682 100051 85038 100402 85056 100652 85076 100650 100650 100688 100739 100661 100655 100664 100648 100803 100782 100673 100652 100725 100764 85025 100718 100742 100694 100714 100631 100681 100665 100684 100657 100754 100705 100720 100748 100645 100686 85080 85050 85077 85029 100721 100708 85039 100653 100603 100610 100653 100728 100747 100744 100700 100695 100685 100663 100794 85018 100759 100753 85033 100788 85019 100777 100719 100715 85034 85017 85049 100655 100668 100670 100668 100671 100670 100675 100674 85024 85043 100693 100368 100506 100802 100620 100779 100791 100606 100605 100607 100609 100613 100630 100676 100634 100633 100660 100743 100723 100731 100729 100679 100724 100702 100699 100761 100641 100647 100741 100690 100601 100626 100618 100629 100649 100658 100689 100675 100671 85059 100661 100672 100696 100101 100632 200045 100022 100374

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 6 of 12

Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1409-2018
Recall number
Z-1409-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
19

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No : 200205 200203 200210 200213 200208 200204 200212 200201 200206 200207 200209 200215 83001 200200 200202 200200 200043 200211 200214

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 7 of 12

Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1410-2018
Recall number
Z-1410-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
106

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial No: 75070 750002 75046 750002 75114 75118 75127 75130 750021 75128 750015 75052 75039 75027 75067 75041 75028 75036 75034 75029 75031 75047 75048 75057 75054 75049 75056 75053 75058 75062 75064 75066 75068 76023 75037 76022 76024 75104 75111 75126 75112 750006 76008 750014 75059 750005 75061 75107 750007 750008 75129 750013 75120 750028 750016 750022 750024 750025 750026 750029 75115 75131 750023 7524 75119 76002 75121 75108 75102 75101 75108 75100 750004 75132 750019 750020 75063 75044 750001 75113 750012 75035 75038 75051 75051 750010 750017 75055 75060 75055 750027 75105 75042 75032 75069 75040 75116 75065 75050 75065 76011 76010 76016 76020 76021 750018

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 8 of 12

Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1411-2018
Recall number
Z-1411-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
119

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 76106 760012 760002 76075 75123 76034 76052 76088 76079 76007 76104 76082 76086 76077 76083 76013 76009 76034 76081 76014 76074 76030 76028 76054 76045 76047 76057 76068 76071 76069 76092 76073 760015 760006 760011 750003 75125 76004 76027 760008 760009 760020 76089 75033 75122 760014 760013 760004 76067 760007 75110 760017 760001 760005 760016 760019 760019 75043 760010 75030 75043 760018 75106 75117 75124 750011 76043 76062 76072 760003 76003 76018 76017 76005 76001 76078 76087 76019 76080 76090 76084 76006 76012 76015 76026 76036 76038 76037 76039 76035 76031 76033 76032 76107 76040 76042 76046 76041 76056 76055 76050 76044 76049 76053 76048 76051 76058 76061 76065 76063 76064 76060 76059 76066 76070 76076 76085 76091 76040

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 9 of 12

Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1412-2018
Recall number
Z-1412-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 50231 30019

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 10 of 12

Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1413-2018
Recall number
Z-1413-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 9541 10207 9890 9633 10561 10655

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 11 of 12

IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1414-2018
Recall number
Z-1414-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
47

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 860023 860035 860047 860059 860010 860014 860015 860013 860029 860006 860002 860061 860011 860020 860024 860008 860039 860043 860018 860012 860022 860032 860033 860040 860009 860016 860017 860042 860003 860005 860037 860041 860025 860038 860036 860052 860056 860021 860053 860019 860054 860044 860028 860030 860026 860031 860034

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.

device · product 12 of 12

Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Z-1415-2018
Recall number
Z-1415-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Code information

Serial no: 30018

Distribution pattern

Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.