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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94508

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

Open FDA event record

Event summary

Timeline bucket
May 03, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America 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

30 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 30

Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343

Z-1836-2024
Recall number
Z-1836-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1585 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (01)00884838004108(21) Serial Number 32307 33454 33668 32302 32401 32679 32699 32814 32894 32913 32923 32974 33002 33071 33073 33224 33227 33386 33387 33485 33488 33493 33502 33503 33518 33551 33571 33683 33704 33713 33746 32306 32475 33569 32075 32797 32326 33175 33519 33364 33702 32853 32100 32112 32186 32193 32216 32223 32243 32276 32277 32278 32301 32304 32339 32358 32367 32377 32484 32487 32493 32502 32565 32569 32570 32574 32598 32641 32655 32671 32695 32747 32782 32790 32843 32882 32893 32895 32897 32908 32912 32914 32945 32946 32959 32977 32981 32988 32995 33000 33011 33013 33055 33060 33064 33067 33074 33076 33101 33116 33118 33129 33134 33135 33136 33148 33184 33189 33190 33199 33225 33242 33244 33245 33254 33255 33275 33283 33286 33289 33293 33296 33305 33311 33330 33333 33335 33367 33370 33372 33388 33399 33402 33406 33408 33412 33414 33463 33478 33479 33480 33494 33526 33527 33539 33540 33541 33542 33543 33544 33545 33547 33549 33563 33564 33566 33567 33568 33570 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32001 32118 32125 32175 32179 32211 32231 32318 32329 32382 32383 32428 32429 32440 32482 32612 32626 32657 32684 32693 32793 32824 32899 32961 33006 33007 33010 33024 33087 33120 33124 33182 33234 33235 33269 33306 33308 33328 33351 33362 33398 33435 33691 33789 13051 21368 12019 32505 32311 32497 32662 32697 33021 33197 33198 32011 32630 33368 33012 32394 32188 32197 32200 33497 32122 32156 32160 32198 32241 32319 32434 32435 32551 32585 32617 32632 32690 32736 32777 32809 32832 32861 32892 32926 32944 32948 32967 32971 33105 33108 33144 33150 33152 33177 33185 33186 33218 33252 33258 33279 33407 33482 33483 33533 33674 33692 33700 33714 32051 32061 32067 32166 32208 32432 32545 32651 32800 32823 32836 32903 32954 32955 33216 33690 33346 32178 32379 32213 32571 32611 32879 32909 32916 33633 32293 32563 32613 32799 33349 33634 32141 32420 32576 32603 32637 32654 32780 32880 32950 33056 33119 33348 33361 33452 33491 33499 33500 33561 33562 33680 32006 32650 33313 33369 32192 32210 32272 32369 32371 32003 32034 32080 32083 32084 32085 32095 32171 32219 32226 32233 32314 32346 32351 32381 32388 32390 32424 32463 32474 32481 32500 32508 32517 32550 32581 32616 32644 32689 32712 32717 32739 32772 32792 32816 32966 33157 33625 32519 32795 33008 33009 33338 33516 33676 32917 33294 21447 32462 32810 32922 33043 33079 33109 33202 33464 33465 32711 (2) Serial Numbers: Serial Number 72018 72020 72104 72137 72138 72146 72157 72160 72170 72171 72179 72183 72185 72190 72200 72223 72233 72238 72251 72269 72013 72111 72112 72113 72231 72235 72270 72271 72272 72273 72315 72079 72083 72109 72120 72122 72123 72124 72126 72139 72140 72141 72142 72147 72150 72247 72007 72156 72101 72116 72117 72180 72197 72267 72189 72204 72325 72327 72008 72080 72036 72052 72057 72081 72103 72134 72143 72144 72145 72151 72186 72199 72217 72224 72227 72228 72236 72253 72254 72255 72256 72257 72258 72259 72260 72264 72278 72279 72296 72297 72298 72299 72304 72330 72029 72129 72153 72175 72194 72207 72280 72281 72290 72301 72302 72310 72311 72316 72320 72321 72326 72329 72075 72076 72261 72019 72022 72047 72100 72154 72159 72240 72244 72285 72287 72306 72317 72324 72328 72005 72015 72016 72023 72071 72074 72205 72038 72322 72048 72001 72032 72323 72058 72230 72234 72102 72201 72003 72040 72114 72010 72049 72055 72136 72148 72195 72266 72319 21300 72222 72053 72062 72063 72077 72118 72121 72128 72173 72176 72177 72188 72192 72196 72202 72203 72232 72265 72274 72288 72294 72308 72313 72034 72198 72220 72226 72119 72168 72303 72309 72312 72318 72012 72025 72066 72193 72237 72331 72174 72059 72082 72249

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 2 of 30

Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346

Z-1837-2024
Recall number
Z-1837-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: 1. (01)00884838068469(21) 2. (01)00884838009806(21) (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060 (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 3 of 30

Achieva 1.5T Initial system Model Number (REF): 781178

Z-1838-2024
Recall number
Z-1838-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 20282, 20303

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 4 of 30

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

Z-1839-2024
Recall number
Z-1839-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
386 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 781345 N/A; (2) 781344 N/A; (3) 781278 (01)00884838004139(21); (4) 781277 N/A; (5) 781177 N/A Serial Numbers: 24079 34231 34256 34289 34220 34308 34139 34200 34213 34255 34258 34276 34301 34306 34020 34052 34082 34113 34120 34123 34230 34234 34235 34239 34240 34247 34260 34264 34270 34272 34274 34285 34287 34288 34297 34298 34299 34309 34312 34056 34282 34023 34144 34228 24115 34001 34095 34138 34143 34165 34269 34293 34300 34305 34115 34225 34253 34038 34047 34077 34126 34135 34160 34206 34254 34268 34275 34118 34237 34271 34273 34291 34242 34261 34290 34033 34104 34281 34086 34106 34125 34159 34241 34263 34286 34294 34295 34311 34022 34043 34208 34109 34130 34203 34207 34304 34074 34028 34029 34030 34034 34065 34066 34071 34073 34085 34201 34011 38295 38074 38191 38247 38254 38276 38326 38346 38355 38363 38285 38043 38073 38087 38092 38098 38108 38124 38140 38152 38157 38158 38171 38181 38185 38189 38190 38194 38196 38206 38209 38210 38212 38215 38216 38227 38231 38233 38236 38238 38240 38245 38248 38249 38252 38255 38257 38258 38260 38264 38266 38267 38269 38270 38271 38279 38282 38284 38287 38292 38293 38298 38299 38303 38304 38307 38314 38318 38319 38320 38321 38324 38327 38328 38329 38330 38332 38335 38338 38339 38340 38343 38344 38347 38349 38351 38358 38360 38361 38367 38368 38370 38372 38401 38402 38405 38407 38408 38410 38412 38414 38415 38420 38421 38423 38424 38425 38426 38427 38429 38430 38431 38432 38433 38436 38437 38438 38439 38441 38442 38443 38445 38447 38448 38450 38453 38454 38456 38457 38458 38128 38288 38082 38174 38253 38044 38049 38079 38139 38141 38151 38167 38170 38188 38220 38228 38127 38145 38009 38034 38162 38251 38336 38354 38359 38055 38056 38278 38207 38021 38031 38054 38059 38061 38086 38095 38104 38115 38133 38137 38169 38186 38187 38193 38223 38237 38262 38273 38280 38313 38272 38322 38323 38337 38345 38200 38268 38090 38172 38265 38046 38150 38197 38217 38225 38261 38067 38130 38022 38047 38093 38241 38060 38138 38017 38064 38069 38112 38113 38143 38144 38154 38160 38205 38229 38234 38246 38256 38274 38291 38296 38297 38315 38331 38099 38003 38011 38078 38006 38057 38072 38085 38283 38302 38004 38016 38018 38033 38091 38103 38173 38341 38232 382320 73005 73008 73009 73002 73003 73004 73006 73010 74027 74034 74035 74041 74009 74004 74039 74047 74052 74001 74002 74010 74020 74026 74033 74046 74032 74005 74007 74021 74029 74030 74044 74048 74037

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 5 of 30

Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781477

Z-1840-2024
Recall number
Z-1840-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 43006

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 6 of 30

Achieva 3.0T TX for PET Model Number (REF): 781479

Z-1841-2024
Recall number
Z-1841-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 43102

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 7 of 30

AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

Z-1842-2024
Recall number
Z-1842-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083 35022 35063 35074 35049 35035 35067 35004 35006 35011 35015 35016 35021 35050 35057 35061 35075 35076 35082 35085

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 8 of 30

Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

Z-1843-2024
Recall number
Z-1843-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 41130 70284 41047 41196 41520 70068 70630 41024 41025 41051 41139 41143 41144 41235 41286 41327 41349 41367 41424 41432 41433 70099 70202 81073 41344 41042 41229 41457 41497 41413 84370 41080 70205 41295 70996 70589 70696 81021 41179 41041 41089 41189 41226 41287 70093 41311 70260 41464 41534 70652 41011 70067 70622 70769 70983

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 9 of 30

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

Z-1844-2024
Recall number
Z-1844-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 42246 85713 42029 71774 85668 85680 85685 85694 85705 42023 42024 42375 42217 42402 71044 85698 85700 85146 85677 85699 71595 71815 85649 42320 85684 71836 85679 85682 85697 85701 85708 85714

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 10 of 30

Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315

Z-1845-2024
Recall number
Z-1845-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2262 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782140 (01)00884838108646(21); (2) 782115 (01)00884838099043(21); (3) 782101 (01)00884838098275(21); (4) 781396 (01)00884838009820(21); (5) 781341 (01)00884838055322(21); (6) 781315 (01)00884838099715(21); Serial Numbers: 61019 61140 61080 61067 61091 61114 61028 61039 61040 61041 61000 61002 61003 61006 61009 61013 61017 61032 61058 61065 61066 61074 61075 61076 61097 61106 61124 61060 61001 61004 61008 61011 61023 61025 61026 61034 61035 61042 61046 61054 61055 61062 61063 61115 61078 61015 61119 61005 61020 61043 61085 61087 61088 61029 61030 61033 61036 61037 61045 61051 61052 61057 61061 61064 61068 61069 61070 61072 61095 61123 61116 61117 61125 61126 61129 61130 61027 61108 61109 61131 61144 61107 61138 61142 61143 61102 61103 61007 61014 61018 61016 61038 61073 61079 61024 61031 61059 61082 61084 61092 61093 61096 61101 61022 61044 61047 61049 61050 61053 61056 61094 61105 61112 61132 87260 70040 70229 70607 70763 84030 84108 84126 84234 84257 84596 87005 87146 70064 70113 70603 70604 70605 70704 70725 70767 70768 70794 70812 84539 70232 70279 70367 70374 70375 70461 70742 70764 70471 70780 84566 84621 84629 84667 87214 87215 70488 70832 70071 70311 70916 84098 84343 84765 70088 70110 70111 70161 70177 70204 70244 70269 70446 70448 70459 70470 70612 70662 70663 70664 70665 70666 70667 70668 70678 70691 70755 70845 70864 70866 70867 70868 70942 70943 70969 84178 84179 84180 84302 84303 84330 84381 84384 84385 84387 84451 84844 84976 87028 87040 87061 87098 87124 87125 87126 87135 87177 87180 87206 87207 87221 87222 87271 87290 87297 84300 84249 84891 70221 70286 70641 70655 70712 70730 70851 70858 84644 84649 70424 84092 84311 84730 84744 84766 84890 84982 84986 87151 87171 87191 70974 70981 70987 70997 84010 84066 84082 84110 84150 84153 84197 84204 84230 84242 84256 84262 84287 84290 84291 84307 84310 84318 84320 84321 84327 84328 84383 84389 84397 84399 84411 84414 84417 84422 84427 84452 84496 84497 84503 84515 84525 84531 84532 84542 84582 84585 84588 84591 84597 84608 84640 84645 84655 84668 84673 84686 84692 84695 84723 84736 84755 84756 84770 84771 84787 84795 84810 84812 84813 84822 84830 84831 84833 84837 84842 84845 84855 84857 84859 84861 84863 84872 84881 84882 84905 84909 84917 84922 84928 84943 84946 84947 84965 84984 84990 84997 87009 87029 87045 87048 87054 87056 87062 87065 87084 87109 87110 87113 87114 87123 87142 87174 87181 87192 87201 87202 87224 87227 87233 87240 87241 87248 87254 87257 87268 87272 87274 87283 87284 87291 87294 87299 87300 87302 87303 87305 87307 87311 87312 87314 87315 87317 87318 87320 87326 87138 84551 70654 84792 87112 70333 70369 70778 70803 70965 84195 84407 84408 84547 84669 84687 70032 70249 70250 70258 84093 84136 84141 84202 84488 87141 84664 70601 87008 70296 70597 70818 70885 70976 70991 84051 84164 84165 84166 84167 84175 84176 84322 84323 84342 84425 84471 84593 84742 87139 87247 87266 84704 84705 70796 84412 70598 70865 70938 70966 70989 84102 84109 84238 84248 84250 84271 84341 84409 84437 84459 84473 84474 84516 84517 84528 84533 84546 84554 84560 84569 84630 84671 84681 84807 84825 84850 84867 84910 84920 84921 87076 70021 70029 70046 70129 70199 70223 70270 70277 70289 70294 70302 70313 70376 70381 70427 70463 70464 70583 70596 70611 70617 70626 70651 70673 70679 70680 70684 70692 70784 70785 70799 70854 70855 70870 70881 70886 70921 70929 70948 70986 70992 70993 84016 84104 84107 84116 84122 84131 84187 84207 84228 84259 84388 84423 84438 84453 84454 84487 84544 84557 84564 84565 84574 84624 84632 84652 84654 84718 84725 84829 84914 84939 84996 87081 87100 87249 87252 70660 87186 87262 84801 84900 84901 70599 70347 70648 70797 84047 84489 84581 84789 87059 87111 70804 84806 70119 70280 70339 70361 70425 70717 70773 70788 70931 70932 70933 70962 84070 84095 84096 84241 84245 84292 84298 84372 84374 84375 84401 84421 84455 84456 84458 84477 84518 84519 84520 84521 84522 84523 84524 84598 84657 84676 84677 84678 84679 84680 84693 84757 84832 84948 84955 87000 87050 87219 87285 87319 84218 70196 70334 70335 70384 70423 70703 70918 70919 84209 84211 84216 84261 84331 84494 84617 84719 84720 87276 87277 87278 87279 87282 87129 87131 87155 87213 87281 70072 70613 70934 70146 70201 70281 70287 70645 70658 70751 70880 84015 84212 84267 87058 87068 70027 70069 70102 70103 70144 70227 70256 70290 70300 70304 70444 70483 70585 70591 70592 70639 70642 70644 70702 70726 70728 70746 70750 70757 70765 70786 70795 70798 70809 70817 70821 70823 70826 70834 70935 70946 70957 70961 70971 70988 84007 84017 84041 84076 84080 84081 84083 84091 84124 84125 84127 84135 84144 84177 84220 84269 84281 84294 84329 84382 84413 84420 84431 84491 84502 84507 84513 84530 84536 84541 84594 84604 84606 84804 84851 84864 84871 84892 84893 84937 84952 84956 84988 84994 84995 87092 87102 87115 87165 87236 70480 70011 70013 70037 70038 70039 70053 70055 70056 70084 70122 70142 70192 70203 70263 70273 70299 70329 70343 70346 70379 70402 70432 70436 70441 70454 70460 70484 70595 70647 70649 70670 70682 70720 70732 70734 70735 70736 70738 70741 70747 70772 70774 70789 70792 70800 70805 70813 70820 70824 70825 70827 70836 70839 70848 70850 70859 70861 70876 70902 70909 70920 70926 70970 70979 84008 84027 84028 84031 84032 84034 84035 84048 84052 84060 84061 84062 84065 84079 84099 84114 84118 84149 84162 84172 84191 84193 84194 84201 84219 84229 84233 84247 84255 84266 84270 84289 84309 84333 84335 84357 84359 84360 84376 84379 84394 84396 84415 84444 84480 84492 84495 84500 84510 84527 84534 84535 84545 84556 84583 84603 84634 84635 84641 84647 84650 84659 84660 84666 84670 84697 84706 84708 84712 84713 84714 84721 84722 84724 84745 84747 84748 84751 84775 84790 84793 84805 84818 84819 84820 84839 84858 84873 84879 84880 84895 84904 84908 84918 84930 84977 84978 84987 87001 87023 87026 87038 87066 87117 87136 87175 87176 87187 87190 87196 87197 87204 87234 87235 87238 87239 87242 87289 87293 84018 84231 84086 84275 84826 84940 87210 70238 70261 70891 84916 87079 84349 84350 84351 84352 84353 84354 84355 84025 84347 70128 70198 70593 87212 84772 84854 87036 87037 70485 70831 70833 84395 84404 84716 70318 87296 70941 70930 84068 70264 70908 84013 84089 84199 84221 84430 84571 84572 84600 84602 84700 84834 84862 84885 84983 84319 84443 84852 70777 70257 70262 70285 70429 70615 70637 70638 70714 70862 70896 70910 70990 70998 84130 84138 84140 84217 84278 84398 84419 84733 70075 70360 70018 70059 70303 70439 70922 70947 70960 84115 84148 84587 84752 87143 87144 70131 70481 70628 70722 84145 70136 84045 84046 70882 70048 70065 70066 70255 70711 87078 87269 70282 84611 70828 84057 84288 84424 70022 70155 70371 70437 70775 70830 84029 84363 84573 84605 84648 84689 87003 84840 70236 70271 70937 84067 84682 84709 84113 84888 70416 70945 84129 87116 70140 70337 70350 70351 70357 70368 70401 70428 70449 70456 70486 70487 70489 70490 70624 70686 70744 70745 70811 70815 70840 70847 70900 70954 70985 84021 84039 84069 84142 84171 84198 84244 84279 84305 84361 84362 84428 84599 84626 84637 84653 84662 84717 84726 84729 84738 84758 84759 84796 84865 84931 84934 84975 84989 87024 87031 87067 87069 87071 87147 87152 87153 87154 87161 87172 87185 87188 87208 87211 87237 87244 87265 87280 70092 70194 70242 70314 70697 70776 70806 70871 70878 70888 84087 84258 84472 84613 84746 84798 84802 87035 87044 87049 87082 87090 87093 70759 70685 70733 84369 70405 70915 84933 70982 70025 70434 70689 70802 84402 84577 84675 84612 84661 84847 70123 70226 70235 70251 70295 70344 70364 70383 70435 70629 70656 70787 70844 70846 70890 70927 70973 84004 84205 84312 84313 84332 84378 84476 84549 84568 84576 84584 84592 84663 84740 84773 84774 84896 87004 87034 87039 87119 87134 70026 70829 70953 70995 84276 84470 70009 70073 70074 70101 70104 70114 70278 70306 70452 70588 70590 70623 70705 70754 70869 70975 84042 84084 84203 84268 84315 84555 84788 87027 70206 70058 70225 70426 70468 70791 70849 84036 84037 84380 84575 84616 84633 84651 84827 84828 84868 87226 70230 84206 84214 84308 84416 84479 84482 84558 84620 84656 84808 84809 84848 70841 70356 70358 70359 70677 70057 70080 70087 70097 70157 70610 70693 70810 84002 84003 84074 84237 84239 84338 84339 84367 84483 84767 84849 84913 84915 84960 84969 87022 87086 87087 87094 87095 87158 87163 87259 84529 70239 87209 70148 70191 70245 70297 70301 70316 70440 70453 70465 70472 70482 70587 70608 70760 70761 70770 70843 70872 70887 70899 70906 70914 70923 70994 84005 84038 84085 84137 84154 84185 84208 84210 84252 84253 84272 84293 84295 84297 84306 84325 84334 84346 84377 84392 84406 84429 84445 84448 84450 84690 84694 84750 84768 84803 84838 84869 87083 87121 87195 87228 87229 87255 70042 70044 70049 70050 70051 70052 70060 70061 70062 70063 70076 70094 70095 70135 70156 70190 70195 70200 70233 70259 70292 70298 70308 70312 70321 70328 70331 70403 70438 70442 70445 70447 70451 70455 70473 70606 70614 70619 70621 70627 70635 70636 70646 70650 70659 70661 70672 70674 70675 70676 70690 70694 70698 70699 70700 70701 70706 70709 70715 70719 70724 70727 70729 70743 70749 70752 70758 70762 70771 70779 70783 70793 70808 70819 70835 70857 70863 70874 70875 70892 70893 70894 70898 70903 70904 70911 70925 70928 70939 70949 70951 70972 70977 84012 84026 84043 84049 84063 84075 84077 84088 84134 84147 84157 84168 84169 84170 84173 84174 84181 84184 84186 84189 84196 84200 84222 84225 84240 84243 84254 84264 84274 84280 84282 84283 84286 84314 84316 84340 84344 84400 84403 84410 84432 84433 84434 84439 84440 84441 84446 84460 84462 84467 84469 84475 84481 84484 84485 84498 84499 84505 84506 84508 84509 84512 84514 84526 84537 84538 84552 84614 84627 84628 84642 84646 84674 84734 84741 84784 84791 84799 84811 84816 84821 84823 84824 84836 84853 84866 84889 84894 84911 84929 84935 84942 84954 84970 84973 84979 84993 87017 87019 87043 87055 87057 87097 87103 87120 87132 87133 87218 87231 87245 70801 70443 70963 70707 84192 70085 70160 70246 70348 70349 70407 70723 70873 70917 87101 70179 70883 84251 84776 84777 84778 84779 84780 84781 84782 84783 70657 70154 70710 87232 41175 41176 41253 41282 41485 41492 41007 41039 41061 41127 41157 41181 41256 41262 41350 41541 41567 41132 41200 41398 41302 41343 413020 413430 41012 41505 41186 41230 41236 41268 41271 41359 41441 41459 41460 41521 41556 41584 41204 41449 41151 41518 41524 41297 41595 41610 41612 41615 41617 41618 41619 41509 41591 41045 41108 41314 41366 41397 41519 41436 41330 41465 41470 41491 41070 41351 41523 41010 41016 41029 41031 41043 41052 41055 41071 41084 41085 41103 41105 41112 41119 41125 41131 41141 41142 41145 41160 41178 41192 41210 41211 41218 41227 41228 41239 41240 41261 41266 41283 41284 41288 41338 41363 41368 41373 41375 41380 41381 41383 41388 41389 41390 41392 41395 41402 41412 41417 41442 41454 41471 41473 41500 41538 41553 41561 41050 41113 41573 41038 41480 41086 41087 41093 41096 41129 41161 41163 41184 41193 41199 41201 41202 41213 41217 41220 41233 41234 41246 41257 41258 41267 41310 41332 41337 41352 41365 41399 41411 41422 41469 41489 41494 41499 41502 41535 41545 41574 41049 41060 41064 41068 41074 41106 41109 41117 41124 41126 41128 41133 41136 41153 41174 41243 41244 41280 41281 41292 41298 41299 41339 41357 41361 41362 41400 41408 41428 41435 41437 41452 41488 41490 41493 41496 41507 41513 41543 41544 41549 41558 41559 41565 41570 41572 41571 41115 41099 41182 41231 41232 41547 41563 41405 41560 41020 41169 41188 41293 41458 41466 41467 41474 41364 41001 41008 41013 41100 41140 41190 41214 41225 41249 41301 41450 41456 41461 41372 41033 41167 41215 41216 41486 41304 41289 41527 41340 41075 41118 41306 41562 41107 41152 41164 41219 41296 41309 41331 41394 41546 41575 41588 41111 41120 41137 41594 41407 41414 41476 41477 41479 41003 41162 41172 41185 41254 41255 41446 41498 41515 41110 41138 41259 41440 41531 41419 41536 41177 41241 41279 41578 41478 41577 41054 41088 41180 41335 41336 41355 41371 41376 41384 41387 41423 41453 41548 41000 41005 41006 41009 41015 41018 41021 41022 41023 41028 41034 41035 41036 41037 41044 41046 41048 41056 41057 41059 41066 41067 41073 41077 41079 41083 41090 41091 41092 41094 41095 41097 41098 41104 41116 41123 41134 41148 41149 41154 41158 41159 41166 41171 41173 41194 41195 41197 41198 41203 41205 41206 41208 41209 41212 41221 41222 41237 41242 41250 41251 41260 41263 41265 41277 41278 41290 41291 41294 41303 41305 41312 41313 41342 41354 41356 41358 41370 41406 41409 41415 41418 41420 41421 41425 41426 41427 41429 41434 41438 41444 41462 41463 41475 41481 41484 41495 41511 41512 41514 41516 41517 41525 41532 41551 41552 41555 41569 41580 41590 41002 41146 41318 41472 41564 41224 41238 41319 41526 41168 87602 87644 87645 87648 87649 87651 87653 87605 87298 87607 87608 87609 87610 87612 87613 87614 87615 87617 87622 87625 87627 87631 87632 87633 87634 87635 87636 87637 87638 87639 87640 87641 87642 87643 87601 87655 61250 61281 61213 61214 61280 61299 61341 61292 61385 61266 61201 61210 61212 61217 61227 61276 61403 61417 61264 61273 61192 61193 61246 61206 61208 61219 61248 61249 61265 61269 61271 61257 61332 61175 61181 61182 61183 61188 61199 61200 61204 61218 61220 61224 61268 61270 61289 61295 61300 61334 61338 61386 61387 61390 61394 61395 61397 61401 61402 61408 61409 61410 61177 61180 61184 61185 61187 61189 61191 61205 61209 61221 61222 61225 61231 61237 61238 61243 61245 61253 61261 61262 61263 61275 61279 61284 61313 61314 61317 61319 61336 61288 61186 61179 61258 61359 61304 61380 61145 61415 61232 61223 61298 61195 61226 61333 61339 61252 61234 61330 61382 61203 61236 61228 61235 61272 61329 61326 61327 61176 61178 61198 61202 61211 61240 61256 61274 61285 61286 61287 61291 61293 61294 61302 61196 61207 61216 61233 61242 61282 61331 61342 61311 61259 61260 45606 45602 45601

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 11 of 30

Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261

Z-1846-2024
Recall number
Z-1846-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 781262 (01)00884838068445(21); (2) 781261 (01)00884838068438(21) Serial Numbers: Serial Number 77008 77000 77004 77001 77019 77010 77014 77007 77002 77016 77131 77070 77124 77144 77172 77074 77048 77177 77178 77181 77031 77047 77134 77050 77051 77060 77194 77034 77037 77038 77057 77072 77075 77078 77084 77085 77086 77092 77101 77110 77156 77157 77035 77111 77119 77167 77183 77185 77187 77188 77195 77196 77198 77199 77202 77052 77053 77054 77055 77056 77064 77065 77066 77067 77068 77069 77105 77125 77126 77135 77136 77137 77138 77139 77148 77141 77030 77032 77033 77036 77042 77043 77044 77049 77059 77061 77071 77083 77087 77088 77090 77091 77093 77097 77100 77106 77107 77112 77115 77118 77120 77121 77128 77129 77143 77151 77155 77158 77161 77162 77190 77191 77201 77166 77045 77063 77109 77117 77123 77081 77147 77113 77168 77169 77122 77154 77046 77094 77130 77062 77140 77039 77040 77058 77114 77127 77159 77160 77171 77179 77180 77182 77150 77041 77103 77203

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 12 of 30

Ingenia 1.5T S Model Number (REF): 781347

Z-1847-2024
Recall number
Z-1847-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
139 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (01)00884838068421(21) Serial Numbers: 81003 81050 81051 81090 81111 81010 81027 81028 81030 81035 81063 81106 81093 81105 81116 81007 81004 81006 81009 81011 81016 81017 81018 81019 81020 81023 81024 81031 81037 81041 81055 81056 81057 81060 81062 81064 81070 81074 81078 81112 81115 81122 81146 81147 81153 81156 81158 81013 81044 81040 81047 81059 81167 81170 81171 81008 81108 81148 81133 81164 81001 81086 81079 81118 81138 81139 81140 81151 81175 81184 81069 81061 81065 81098 81085 81091 81092 81032 81043 81129 81131 81149 81155 81162 81165 81172 81180 81084 81087 81088 81094 81095 81100 81127 81132 81174 81157 81176 81071 81052 81067 81039 81038 81179 81185 81117 81173 81154 81025 81097 81152 81015 81029 81033 81034 81042 81046 81048 81049 81058 81072 81080 81103 81113 81123 81128 81137 81045 81075 81076 81077 81096 81114 81124 81126 81145 81159 81178

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 13 of 30

Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342

Z-1848-2024
Recall number
Z-1848-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1517 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782103 (01)00884838098299(21); (2) 781377 (01)00884838009813(21); (3) 781342 (01)00884838055339(21) Serial Numbers: Serial Number 85106 71011 71152 71403 71433 71526 71710 71812 71817 71101 71168 71178 71179 71214 71252 71309 71313 71328 71342 71419 71453 71550 71551 71555 71557 71674 71693 71733 71859 71949 71993 71994 85036 85045 85155 71266 71311 71345 71392 71395 71628 71723 85393 71216 71651 85208 71163 71408 71493 71499 71541 71668 71729 71771 71602 71260 71276 71324 71800 71726 71068 71081 71300 71482 71481 71339 71730 71452 71464 71465 71467 71468 71470 71471 71472 71473 71479 71480 71492 71497 71505 71506 71509 71511 71514 71516 71517 71519 71520 71544 71548 71553 71554 71559 71560 71567 71588 71594 71596 71601 71605 71609 71610 71614 71621 71622 71624 71626 71629 71631 71633 71637 71642 71653 71654 71656 71685 71687 71690 71692 71695 71698 71699 71702 71707 71708 71709 71713 71714 71716 71734 71738 71742 71744 71745 71755 71765 71775 71779 71782 71783 71784 71786 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71396 71400 71440 71501 71521 71576 71590 71603 71607 71725 71751 71773 71791 71838 71874 85025 85031 85161 85180 85276 85319 85341 85342 85391 71394 71346 71704 71910 71983 85063 85183 85205 85206 85216 71334 71409 71476 85023 71061 71087 71106 71162 71165 71181 71280 71349 71351 71357 71389 71393 71410 71422 71428 71460 71477 71500 71512 71518 71643 71677 71691 71717 71743 71750 71762 71763 71842 71854 71900 71966 71967 85122 85140 85147 85149 85190 85203 85210 85224 85318 85347 71367 71461 71545 85241 85302 85348 85372 85459 71423 71184 71462 71619 71620 71164 71177 71326 71424 71639 71681 71688 71758 71759 71863 71892 85057 85245 85246 85250 85286 71926 71001 71002 71004 71007 71012 71013 71014 71035 71037 71039 71056 71070 71089 71093 71095 71154 71155 71174 71175 71183 71210 71211 71228 71268 71269 71271 71282 71301 71341 71347 71361 71385 71401 71411 71413 71416 71425 71427 71429 71438 71441 71450 71463 71489 71491 71498 71527 71558 71562 71587 71589 71592 71635 71652 71655 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42557 42558 42560 42561 42563 42565 42570 42559 42042 42313 42178 42384 42041 42092 42005 42013 42015 42021 42025 42027 42028 42030 42061 42073 42081 42082 42090 42107 42130 42138 42141 42143 42144 42145 42216 42279 42292 42308 42315 42363 42369 42044 42089 42232 42318 42086 42272 42026 42047 42072 42110 42184 42191 42192 42195 42218 42225 42284 42285 42364 42407 42426 42440 42172 42136 42137 42199 42275 42287 42014 42048 42056 42070 42074 42077 42078 42093 42094 42095 42103 42112 42115 42121 42124 42128 42133 42161 42162 42179 42203 42205 42210 42219 42222 42233 42237 42245 42249 42250 42252 42253 42254 42257 42260 42261 42262 42263 42276 42278 42282 42288 42289 42299 42300 42301 42309 42314 42330 42331 42333 42337 42345 42347 42349 42360 42361 42378 42381 42383 42385 42392 42396 42404 42409 42412 42420 42421 42422 42424 42425 42432 42442 42062 42122 42428 42294 42069 42019 42390 42451 42017 42135 42209 42228 42271 42408 42008 42234 42235 42236 42353 42244 42355 42455 42256 42340 42043 42359 42438 42087 42120 42170 42201 42267 42386 42401 42415 42449 42450 42211 42265 42321 42018 42105 42007 42009 42010 42011 42012 42037 42065 42079 42132 42134 42164 42165 42176 42230 42303 42332 42338 42350 42351 42388 42399 42419 42058 42264 42131 42348 42273 42055 42220 42323 42358 42413 42001 42003 42006 42031 42032 42033 42034 42035 42036 42038 42040 42045 42049 42050 42052 42053 42057 42059 42066 42067 42068 42076 42083 42096 42098 42099 42100 42101 42102 42104 42109 42111 42116 42117 42119 42123 42126 42127 42150 42152 42158 42159 42160 42163 42169 42173 42177 42180 42185 42187 42193 42196 42197 42214 42229 42238 42240 42241 42242 42247 42248 42258 42266 42274 42286 42293 42298 42307 42322 42328 42334 42342 42352 42356 42365 42366 42368 42370 42376 42389 42400 42403 42414 42416 42429 42189 42004 42204 85667 85622 85625 85626 85628 85629 85630 85631 85633 85636 85637 85638 85641 85642 85650 85656 85657 85658 85659 85660 85662 85692 85715 85722 85725 85727 85696 85620 85601 85604 85606 85608 85614 85672 85674 85720 85730 85732 85693 85704 85706 85675 85687 85688 85690 85695 85619 85676 85718 85707 85613 85646 85611 85612 85615 85703 85719 85600 85607 85616 85617 85666 85664 85686 85663 85681 85651 85652 85654 85643 85644 85653 85655

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 14 of 30

Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271

Z-1849-2024
Recall number
Z-1849-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) (01)00884838098312(21); (2) (01)00884838068452(21) Serial Number 78121 78150 78157 78096 78208 78094 78012 78074 78154 78161 78170 78171 78172 78173 78182 78183 78189 78190 78196 78198 78205 78210 78212 78213 78216 78218 78221 78225 78233 78235 78238 78240 78241 78242 78243 78244 78250 78251 78252 78253 78256 78257 78262 78263 78265 78266 78267 78268 78269 78270 78271 78272 78273 78279 78280 78281 78282 78283 78284 78288 78289 78291 78292 78293 78294 78295 78296 78301 78305 78306 78307 78308 78309 78310 78312 78313 78314 78316 78317 78319 78320 78321 78322 78323 78327 78328 78329 78330 78332 78333 78334 78335 78338 78339 78340 78341 78342 78343 78345 78346 78347 78352 78353 78354 78356 78357 78358 78359 78360 78361 78362 78363 78364 78366 78368 78370 78374 78375 78376 78377 78386 78078 78080 78224 78098 78003 78017 78065 78070 78076 78081 78087 78097 78099 78101 78104 78107 78126 78149 78151 78181 78206 78219 78264 23032 78063 78064 78106 78187 78000 78005 78007 78009 78010 78015 78016 78018 78019 78021 78023 78025 78027 78029 78031 78032 78033 78035 78038 78039 78040 78042 78043 78045 78048 78049 78050 78051 78062 78067 78068 78072 78082 78083 78084 78088 78089 78091 78095 78100 78109 78111 78113 78114 78115 78117 78127 78129 78132 78133 78139 78140 78145 78147 78148 78155 78199 78203 78207 78214 78222 78223 78004 78008 78053 78011 78013 78014 78028 78034 78044 78046 78047 78058 78060 78066 78071 78073 78075 78077 78086 78092 78102 78103 78110 78112 78118 78120 78122 78123 78128 78135 78137 78138 78141 78142 78158 78162 78164 78166 78167 78175 78180 78186 78188 78193 78194 78195 78197 78201 78202 78209 78215 78217 78227 78229 78232 78234 78239 78247 78254 78255 78259 78260 78261 78277 78286 78287 78290 78297 78298 78299 78324 78326 78336 78337 78030 78036 78059 78156 78249 78026 78022 78516 78517 78518 78519 78521 78522 78523 78524 78525 78526 78527 78528 78529 78530 78531 78536 78537 78539 78545 78546 78547 78548 78549 78550 78551 78553 78554 78556 78557 78559 78560 78561 78562 78564 78565 78567 78500 78501 78503 78504 78505 78507 78508 78512 78513 78532 78533 78535 78538 78540 78541 78542 78543 78544 78552 78566 78568

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 15 of 30

Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359

Z-1850-2024
Recall number
Z-1850-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
328 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782139 (01)00884838108639(21); (2) 782133 N/A; (3) 782108 (01)00884838098343(21); (4) 781359 (01)00884838090057(21) Serial Numbers: Serial Number 48016 48053 48126 48003 48136 48285 48144 48020 48030 48124 48155 48191 48216 48218 48245 48300 48183 48186 48187 48222 48225 48234 48240 48241 48249 48269 48278 48284 48288 48293 48294 48299 48304 48313 48317 48326 48331 48051 48223 48207 48028 48031 48049 48050 48131 48134 48154 48160 48242 48254 48219 48000 48004 48005 48009 48019 48032 48132 48145 48224 48244 48040 48122 48039 48022 48152 48173 48012 48014 48036 48037 48044 48127 48151 48158 48174 48184 48043 48046 48047 48055 48128 48129 48153 48178 48180 48190 48192 48194 48226 48275 48181 48198 48199 48200 48023 48033 48045 48001 48038 48167 48185 48196 48236 48238 48239 48034 48276 48010 48170 48035 48172 48027 48248 48146 48147 48148 48163 48164 48165 48169 48182 48188 48271 48291 48297 48302 48303 48308 48309 48310 48329 48018 48283 48177 48011 48017 48056 48250 48272 48253 48268 48013 48015 48052 48112 48120 48130 48162 48166 48171 48179 48214 48217 48233 48237 48243 48252 48273 48274 48286 48287 48314 48026 48322 48133 48316 48558 48572 48566 48581 48592 48652 48800 48893 48544 48506 48520 48521 48534 48551 48712 48714 48715 48810 48813 48833 48883 48885 48538 48539 48602 48613 48650 48501 48502 48507 48514 48530 48540 48568 48569 48577 48579 48580 48590 48591 48614 48620 48629 48632 48638 48641 48503 48606 48660 48529 48609 48622 48541 48549 48616 48504 48508 48513 48524 48536 48537 48555 48560 48571 48573 48585 48593 48594 48597 48600 48522 48561 48564 48668 48726 48519 48532 48533 48505 48510 48567 48604 48515 48584 48512 48582 48647 48850 48610 48615 48500 48523 48535 48546 48552 48554 48562 48575 48578 48586 48637 48645 48648 48656 48525 48526 27500 27502 27504 27505 27506 27507 27508 27509 27511 27512 27514 27515 27516 27517 27518 27519 27520 27522 27523 27524 27525 27526 27527 27528 27529 27530 27531 27532 27533 27535 27536 27539 27541 27542 27543 27544 29021 29000 29010 29011 29012 29014 29017 29018 29025 29003 29006 29009 29015 29023 29013 29027 29005 29019

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 16 of 30

Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356

Z-1851-2024
Recall number
Z-1851-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
509 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number 47194 47040 47092 47091 47048 47195 47345 47361 47050 47209 47246 47247 47293 47254 47275 47019 47049 47200 47356 47357 47197 47270 47013 47014 47015 47053 47065 47082 47099 47268 47274 47000 47002 47003 47017 47020 47024 47035 47047 47056 47058 47074 47078 47089 47097 47192 47225 47337 47226 47227 47341 47307 47364 47365 47372 47284 47350 47057 47075 47081 47088 47174 47175 47188 47193 47288 47052 47059 47072 47085 47184 47187 47211 47252 47262 47304 47328 47342 47384 47064 47244 47219 47220 47298 47094 47329 47096 47207 47283 47190 47264 47309 47034 47202 47315 47332 47367 47385 47016 47269 47382 47352 47012 47021 47221 47276 47297 47313 47314 47271 47281 47001 47032 47041 47248 47255 47258 47301 47311 47272 47306 47009 47023 47030 47080 47083 47189 47215 47222 47230 47231 47242 47245 47286 47299 47302 47310 47312 47004 47006 47007 47011 47018 47022 47025 47026 47027 47028 47029 47033 47037 47038 47039 47043 47044 47045 47051 47054 47060 47061 47062 47063 47066 47067 47068 47070 47071 47084 47090 47093 47095 47098 47177 47183 47185 47196 47198 47199 47203 47204 47205 47206 47208 47210 47216 47233 47237 47251 47253 47260 47278 47279 47280 47282 47289 47290 47291 47292 47294 47303 47305 47316 47322 47323 47324 47325 47330 47331 47333 47335 47336 47338 47339 47340 47344 47346 47347 47348 47351 47353 47370 47371 47377 47378 47380 47387 47173 47077 47657 47866 47531 47540 47878 47612 47717 47518 47519 47523 47526 47552 47555 47573 47584 47839 47565 47644 47742 47585 47582 47885 47669 47748 47755 47507 47508 47505 47570 47610 47500 47527 47529 47545 47640 47725 47778 47855 47532 47533 47547 47548 47591 47831 47843 47882 47607 47583 47625 47626 47627 47628 47629 47630 47675 47676 47786 47509 47525 47765 47848 47517 47504 47579 47683 47688 47737 47784 47808 47810 47812 47511 47520 47536 47543 47553 47561 47562 47564 47634 47646 47671 47681 47694 47698 47706 47708 47751 47603 47623 47705 47578 47516 47841 47502 47716 47754 47782 47783 47649 47656 47798 47665 47557 47589 47834 47876 47550 47790 47513 47602 47528 47770 47804 47860 47883 47785 47791 47874 47549 47635 47512 47648 47674 47696 47747 47806 47807 47864 47535 47588 47614 47615 47617 47651 47652 47660 47661 47662 47663 47709 47710 47711 47718 47720 47721 47722 47723 47724 47727 47728 47729 47730 47731 47780 47781 47851 47884 47503 47560 47530 47546 47563 47680 47685 47697 47811 47845 47566 47597 47679 47695 47753 47577 47701 47738 47514 47521 47522 47539 47559 47594 47595 47596 47622 47632 47666 47667 47677 47678 47684 47792 47801 47534 47538 47541 47542 47554 47558 47567 47568 47569 47572 47574 47575 47576 47580 47590 47598 47599 47606 47608 47621 47642 47653 47654 47659 47668 47672 47682 47687 47692 47700 47702 47703 47726 47732 47733 47739 47740 47759 47761 47762 47763 47767 47771 47789 47794 47796 47799 47800 47802 47814 47815 47816 47820 47824 47835 47849 47859 47861 47862 47888 47609 49004 49000 49091 49019 49062 49015 49044 49045 49052 49053 49058 49071 49054 49013 49047 49001 49002 49003 49066 49008 49009 49010 49064 49097 49017 49057

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 17 of 30

Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358

Z-1852-2024
Recall number
Z-1852-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (01)00884838088115(21) Serial Number: 45030

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 18 of 30

Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295

Z-1853-2024
Recall number
Z-1853-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 19 of 30

MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110

Z-1854-2024
Recall number
Z-1854-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782152 N/A (2) 782110 (01)00884838099364(21) Serial Numbers: 79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185 Serial Number: 30199 30200 30201 30062 30191 30240 30241 30242 30305 30315 30125 30088 30113 30222 30252 30268 30028 30038 30058 30069 30081 30095 30100 30117 30118 30138 30164 30167 30168 30169 30170 30192 30197 30207 30209 30217 30228 30246 30248 30249 30256 30262 30267 30281 30284 30289 30297 30298 30306 30307 30312 30314 30210 30219 30245 30254 30276 30029 30043 30052 30061 30083 30101 30107 30114 30115 30116 30119 30120 30122 30130 30137 30140 30153 30154 30158 30159 30160 30163 30173 30174 30177 30178 30179 30196 30203 30251 30253 30259 30265 30266 30277 30279 30280 30282 30285 30291 30293 30104 30105 30216 30244 30290 30308 30316 30070 30208 30102 30112 30133 30206 30214 30224 30238 30261 30264 30274 30295 30303 30051 30084 30149 30215 30227 30232 30233 30234 30235 30035 30055 30143 30148 30272 30288 30294 8281 30304 30142 30218 30109 30131 30063 30091 30094 30202 30059 30099 30175 30176 30198 30237 30263 30269 30270 30302 30309 8002 8143 8122 8855 8404 30053 30075 30145 30064 30065 30123 30171 30085 30190 30226 30230 30231 30213 30135 30152 30155 30180 30181 30182 30183 30184 30185 30186 30187 30189 30220 30221 30223 30243 30250 30283 30310 30311 30017 30030 30047 30098 10193

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 20 of 30

Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781350

Z-1855-2024
Recall number
Z-1855-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
118 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782152 N/A (2) 782110 (01)00884838099364(21) Serial Numbers: Serial Number 37019 37067 37149 37188 37184 37034 37036 37058 37167 37173 37183 37195 37197 37009 37011 37013 37020 37027 37031 37050 37055 37080 37093 37100 37121 37127 37132 37137 37141 37143 37150 37157 37170 37180 37193 37194 37023 37044 37066 37071 37106 37124 37160 37175 37182 37192 37022 37068 37082 37129 37134 37145 37156 37171 37181 37187 19083 37161 37178 37088 37024 37098 37135 37139 37176 37153 37060 37116 37196 37015 37073 37109 37122 37133 37162 37185 37026 37096 37177 37002 37012 37017 37029 37039 37041 37047 37048 37052 37053 37056 37077 37083 37084 37086 37087 37095 37102 37104 37107 37110 37113 37120 37123 37125 37128 37130 37136 37142 37158 37159 37163 37165 37168 37189 37069 37174 37126

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 21 of 30

Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474

Z-1856-2024
Recall number
Z-1856-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: Serial Number 79113 79118 79127 79157 79122 79147 79105 79150 79152 79183 79192 79102 79108 79112 79115 79116 79153 79156 79162 79163 79164 79168 79188 79189 79100 79126 79179 79143 79159 79104 79132 79160 79182 79165 79107 79158 79175 79136 79138 79139 79184 79176 79180 79171 79172 79111 79125 79134 79135 79148 79177 79181 79173 79187 79190 79133 79110 79101 79117 79166 79124 79123 79130 79174 79178 79151 79114 79103 79106 79121 79128 79129 79137 79140 79155 79161 79167 79169 79170 79185

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 22 of 30

MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483

Z-1857-2024
Recall number
Z-1857-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 79010 79008 79006 79009 79011 79003 79004 79002 79012 79005

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 23 of 30

MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439

Z-1858-2024
Recall number
Z-1858-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 45, 47

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 24 of 30

MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

Z-1859-2024
Recall number
Z-1859-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 70980, 71569

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 25 of 30

SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260

Z-1860-2024
Recall number
Z-1860-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
617 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 8750 8554 9013 18574 18801 18988 20211 33385 8646 8156 8178 8752 10139 10164 11076 21379 8118 21175 72250 33044 33246 11100 18583 18746 18853 18965 18986 20003 20115 21138 21349 21384 21748 22144 22266 18561 20116 5572 8240 8734 8808 8985 10183 12030 21466 8713 8917 10087 10130 18673 18701 18803 21775 18872 8090 22220 8087 8215 8601 8923 13026 18690 21003 21458 8427 10528 10900 8862 21333 21710 21768 22255 22256 22257 21050 21554 22070 5425 5447 5463 5484 5536 5539 5550 8001 8010 8025 8084 8096 8129 8175 8179 8263 8318 8321 8387 8397 8401 8407 8456 8476 8559 8611 8642 8704 8736 8804 8885 9020 10008 10033 10061 10075 10117 10170 10174 10179 10191 10717 11000 11001 11030 11031 11102 11108 12082 12121 13082 18013 18565 18631 18644 18697 18894 18906 18938 18957 20057 20070 20160 21015 21018 21020 21082 21142 21171 21453 21814 21932 21979 22194 21033 5523 18665 8512 5499 5505 8657 21296 10029 8054 8350 11064 11072 12053 13011 18575 18718 18720 18940 20032 20055 20206 20295 21004 21087 21091 21141 21184 21210 21223 21247 21261 21347 21451 21555 21576 21582 21611 21680 21691 21694 21737 21739 21755 21863 21912 21942 22017 22018 22086 22093 22103 22224 21801 8213 5466 5537 5546 8045 8311 8330 8365 8395 8424 8431 8478 8641 8667 8712 8786 8840 9004 10044 10102 10220 10457 10552 10554 11017 11046 13001 18069 18101 18509 18511 18548 18655 18788 18970 20111 20132 20164 20165 20196 20413 21011 21032 21362 21551 21565 21623 21671 21746 21809 21890 21892 22044 22055 22296 22299 8591 18597 5511 8012 8057 8060 8094 8305 8309 8481 8517 8531 8711 8724 8831 8843 8857 8887 8896 8913 8949 9007 10007 10151 10498 10513 10906 10913 11005 11042 11091 12114 12120 13029 13046 13047 13062 13073 18017 18038 18060 18107 18524 18670 18704 18929 20002 20011 20035 20187 20195 20209 20237 20263 20278 20288 20302 20319 21062 21089 21129 21156 21182 21209 21213 21222 21278 21326 21355 21403 21448 21482 21519 21560 21579 21640 21697 21759 21780 21792 21969 21987 22013 22031 22098 22123 22157 22175 22184 22248 10915 10544 21253 8555 21804 18808 22237 8091 10230 11022 12169 18610 18800 18948 21067 21481 8378 8639 8686 18663 18699 20322 21019 21023 21359 22347 8566 8086 8292 8608 8783 10543 21591 21994 21995 10086 8983 18985 21621 8166 8723 10161 10530 22301 22342 8168 8451 21498 18512 21929 22152 21143 21612 8616 8706 20112 10570 11018 8354 8694 9006 13069 5479 5490 8081 8485 8550 8746 8779 8799 8819 9032 10461 10716 12009 12047 21133 21294 21477 21577 8200 8948 11085 12072 12134 13018 21438 21888 22060 22100 22102 22127 22137 8190 8260 8942 12084 21736 8392 12115 20182 22107 8492 8884 8895 10079 20151 20152 20198 21084 21880 5475 8100 8352 8560 8578 8630 8760 8772 8835 8906 8954 8971 8975 9001 10036 10154 10196 10482 10703 12034 18558 18559 18726 20071 20226 21108 21290 21664 21665 18857 21684 32250 8552 18776 21771 21803 22045 22048 32106 32827 33103 33371 33404 75021 18942 21608 21726 22247 32295 32673 32724 33019 30054 32419 32803 32804 33033 72208 72291 22141 8798 10169 10190 10521 12029 13021 21090 21158 21685 21740 22027 32041 39106 75028 75067 8298 18714 18696 10040 18510 32469 21940 32539 8573 10128 20099 20159 21433 21893 22290 32457 32577 32580 32661 32719 32725 32798 33082 75012 8109 8876 10222 12002 18520 18651 18892 18950 18959 20171 21205 21212 21298 21513 21939 22328 32244 32348 32355 32375 32349 32844 8433 30273 32287 33639 32133 21164 32327 32378 33217 10028 30031 13023 21127 21297 33048 72275 18998 22051 22298 32412 33635 32363 32364 8766 32426 22267 22258 32610 32859 39070 10221 20204 39021 13013 21990

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 26 of 30

SmartPath to dStream for 3.0T Model Number (REF): 782145

Z-1861-2024
Recall number
Z-1861-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Numbers: 17377 34114 38294

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 27 of 30

SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270

Z-1862-2024
Recall number
Z-1862-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
200 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (1) 782129 (01)00884838105805(21); (2) 782113 (01)00884838098909(21); (3) 781270 (01)00884838095083(21) Serial Numbers: Serial Number 17536 17546 17212 17508 23011 35056 17434 17302 17429 24108 17006 17378 17386 17533 17590 35052 17204 17264 17292 17339 17398 17415 17416 17436 17440 17447 17544 23030 24055 35087 17473 17283 17247 17265 17268 17286 17353 17367 17389 17425 17509 17517 17572 17580 24022 24036 24098 35020 35078 23002 24018 17514 17524 23026 24087 24095 17260 17222 17242 17245 17250 17269 17299 17308 17309 17342 17357 17388 17399 17464 17468 17493 17499 17556 17559 17564 17565 17569 17589 17594 24006 24012 24023 24047 24109 24110 24111 24124 24134 24143 35027 35046 35048 38015 17305 24117 17266 17471 17428 38131 17194 17246 23036 17610 17550 24145 34250 17237 17352 17321 17344 17495 17570 17615 24020 24090 17274 35047 17326 17466 24075 17172 17360 17369 17490 24007 24025 38199 17356 17406 17206 17239 17240 17284 17375 17459 17516 23033 24058 24076 35019 35032 35040 17366 17215 17376 17449 17455 17470 34059 34262 38106 17252 34172 38070 38142 17439 38350 74040 17504 34072 35041 38105 17271 17346 24021 24077 24093 24146 34117 34127 34128 34129 34131 34153 34202 35059 38094 38290 38311 17258 38310 34212 38042 38281 17560 38166 38183 24039 34110 38117 17521 38010 38219 17307 38075 38222 34055 38195

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 28 of 30

SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

Z-1863-2024
Recall number
Z-1863-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 29 of 30

Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361

Z-1864-2024
Recall number
Z-1864-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Number: 6102 6115 6101 34007

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

device · product 30 of 30

Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127

Z-1865-2024
Recall number
Z-1865-2024
Initiated
May 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Code information

UDI-DI: N/A Serial Number: 65007

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.