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U.S. Department of Health and Human Services

Class 2 Device Recall POWERLED II

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 Class 2 Device Recall POWERLED IIsee related information
Date Initiated by FirmNovember 08, 2023
Date PostedJanuary 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0757-2024
Recall Event ID 93567
Product Classification Lamp, surgical - Product Code FTD
ProductMaquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT629117A, PWDII75DF - ARDPWT629118A, PWDII75SF - ARDPWT629119A, PWDII50DF - ARDPWT629120A, PWDII50SF - ARDPWT629121A, PWDII50SF - ARDPWT629122A, PWDII55DF - ARDPWT629123A, PWDII55SF - ARDPWT629124A, PWDII70DF - ARDPWT629125A, PWDII70DF - ARDPWT629126A, PWDII70SF - ARDPWT629127A, PWDII70SF - ARDPWT629128A, PWDII75DF - ARDPWT629129A, PWDII75SF - ARDPWT629130A, PWDII50DF - ARDPWT629131A, PWDII50SF - ARDPWT629132A, PWDII50SF - ARDPWT629133A, PWDII55DF - ARDPWT629134A, PWDII55SF - ARDPWT629135A, PWDII70DF - ARDPWT629136A, PWDII70DF - ARDPWT629137A, PWDII70SF - ARDPWT629138A, PWDII70SF - ARDPWT629139A, PWDII75DF - ARDPWT629140A, PWDII75SF - ARDPWT629141A, PWDII50DF - ARDPWT629142A, PWDII50SF - ARDPWT629143A, PWDII50SF - ARDPWT629144A, PWDII55DF - ARDPWT629145A, PWDII55SF - ARDPWT629146A, PWDII70DF - ARDPWT629147A, PWDII70DF - ARDPWT629148A, PWDII70SF - ARDPWT629149A, PWDII70SF - ARDPWT629150A, PWDII75DF - ARDPWT629151A, PWDII75SF - ARDPWT629152A, PWDII50DF - ARDPWT629154A, PWDII50DF - ARDPWT629155A, PWDII77SF - ARDPWT629156A, PWDII50DF - ARDPWT639001A, PWDII50DF - ARDPWT639002A, PWDII50DF - ARDPWT639003A, PWDII50DF - ARDPWT639004A, PWDII50SF - ARDPWT639006A, PWDII50SF - ARDPWT639007A, PWDII50SF - ARDPWT639008A, PWDII50SF - ARDPWT639009A, PWDII70DF - ARDPWT639011A, PWDII70DF - ARDPWT639012A, PWDII70DF - ARDPWT639013A, PWDII70DF - ARDPWT639014A, PWDII70SF - ARDPWT639016A, PWDII70SF - ARDPWT639017A, PWDII70SF - ARDPWT639018A, PWDII70SF - ARDPWT639019A, PWDII70DF - ARDPWT639021A, PWDII50DF - ARDPWT639022A, PWDII50DF - ARDPWT639023A, PWDII50DF - ARDPWT639024A, PWDII50DF - ARDPWT639025A, PWDII50SF - ARDPWT639027A, PWDII50SF - ARDPWT639028A, PWDII50SF - ARDPWT639029A, PWDII50SF - ARDPWT639030A, PWDII70DF - ARDPWT639032A, PWDII70DF - ARDPWT639033A, PWDII70DF - ARDPWT639034A, PWDII70DF - ARDPWT639035A, PWDII70SF - ARDPWT639037A, PWDII70SF - ARDPWT639038A, PWDII70SF - ARDPWT639039A, PWDII70SF - ARDPWT639040A, PWDII70DF - ARDPWT639042A, PWDII50DF - ARDPWT639043A, PWDII50DF - ARDPWT639044A, PWDII50DF - ARDPWT639045A, PWDII50DF - ARDPWT639046A, PWDII55DF - ARDPWT639048A, PWDII55DF - ARDPWT639049A, PWDII55DF - ARDPWT639050A, PWDII75DF - ARDPWT639052A, PWDII75DF - ARDPWT639053A, PWDII75DF - ARDPWT639054A, PWDII50SF - ARDPWT639056A, PWDII50SF - ARDPWT639057A, PWDII50SF - ARDPWT639058A, PWDII50SF - ARDPWT639059A, PWDII55DF - ARDPWT639061A, PWDII55DF - ARDPWT639063A, PWDII55SF - ARDPWT639064A, PWDII55SF - ARDPWT639066A, PWDII55SF - ARDPWT639067A, PWDII55SF - ARDPWT639068A, PWDII55SF - ARDPWT639069A, PWDII70DF - ARDPWT639071A, PWDII70DF - ARDPWT639072A, PWDII70DF - ARDPWT639073A, PWDII70DF - ARDPWT639074A, PWDII70DF - ARDPWT639076A, PWDII70SF - ARDPWT639077A, PWDII70SF - ARDPWT639078A, PWDII70SF - ARDPWT639079A, PWDII70SF - ARDPWT639080A, PWDII75DF - ARDPWT639082A, PWDII75DF - ARDPWT639084A, PWDII75SF - ARDPWT639086A, PWDII75SF - ARDPWT639088A, PWDII75SF - ARDPWT639089A, PWDII75SF - ARDPWT639090A, PWDII75SF - ARDPWT639091A, PWDII77DF - ARDPWT639093A, PWDII77DF - ARDPWT639095A, PWDII77DF - ARDPWT639096A, PWDII77DF - ARDPWT639098A, PWDII77DF - ARDPWT639099A, PWDII77SF - ARDPWT639101A, PWDII77SF - ARDPWT639103A, PWDII77SF - ARDPWT639104A, PWDII77SF - ARDPWT639105A, PWDII77SF - ARDPWT639106A, PWDII50DF - ARDPWT639108A, PWDII50DF - ARDPWT639109A, PWDII50DF - ARDPWT639110A, PWDII50DF - ARDPWT639111A, PWDII55DF - ARDPWT639113A, PWDII55DF - ARDPWT639114A, PWDII55DF - ARDPWT639115A, PWDII75DF - ARDPWT639117A, PWDII75DF - ARDPWT639118A, PWDII75DF - ARDPWT639119A, PWDII50SF -
Code Information All systems affected UDI-DI: 03700712414207 03700712407094 03700712407087 03700712407070 03700712406141 3700712407148 3700712407155 3700712407377 3700712407384 3700712407605 3700712407612 3700712407834 3700712407841 3700712406172 3700712406288 3700712406448 3700712406479 3700712406608 3700712406615 3700712406639 3700712406660 3700712416027 3700712419820 3700712408060 3700712408336 3700712411336 3700712411596 3700712406684 3700712406967 3700712406691 3700712406882 3700712416904 3700712416966 3700712417321 3700712419424 3700712418434 3700712409722 3700712409135 3700712417352 3700712418526 3700712418533 3700712409654 3700712409098 3700712417338 3700712416690 3700712416706 3700712409180 3700712408664 3700712417345 3700712416713 3700712416720 3700712409821 3700712409333 3700712417369 3700712416737 3700712416751 3700712409609 3700712409043 3700712417383 3700712416744 3700712416768 3700712409524 3700712409005 3700712412531 3700712412548 3700712412555 3700712410445 3700712410056 3700712417376 3700712416010 3700712413279 3700712410292 3700712409975 3700712414221 3700712414214 3700712415075 3700712415082 3700712415235 3700712415242 3700712415259 3700712415266 3700712417406 3700712419462 3700712418366 3700712409456 3700712408961 3700712417420 3700712418403 3700712418410 3700712409395 3700712408923 3700712417390 3700712416775 3700712416782 3700712412326 3700712408800 3700712417413 3700712416799 3700712416133 3700712412319 3700712408794 3700712417437 3700712419448 3700712418557 3700712409326 3700712408886 3700712417444 3700712418625 3700712418632 3700712409265 3700712408848 3700712413262 3700712413255 3700712412838 3700712410193 3700712409708 3700712413217 3700712413200 3700712413194 3700712410117 3700712409586 3700712415426 3700712415433 3700712414986 3700712414993 3700712414382 3700712414405 3700712414481 3700712414498 3700712410544 3700712410551 3700712410568 3700712410575 3700712410582 3700712410599 3700712410605 3700712410612 3700712415273 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3700712409036 3700712417505 3700712418328 3700712418335 3700712409500 3700712408992 3700712412494 3700712412500 3700712412517 3700712410223 3700712410018 3700712412609 3700712412616 3700712412623 3700712410346 3700712409944 3700712415112 3700712415129 3700712415297 3700712415303 3700712417529 3700712419479 3700712418373 3700712409432 3700712408954 3700712417543 3700712418380 3700712418397 3700712409371 3700712408916 3700712416621 3700712408787 3700712412289 3700712416959 3700712408770 3700712412302 3700712417567 3700712419455 3700712418564 3700712409319 3700712408879 3700712417581 3700712418601 3700712418618 3700712409258 3700712408831 3700712412913 3700712409616 3700712410155 3700712412753 3700712409494 3700712410230 3700712416676 3700712416225 3700712416683 3700712416218 3700712417512 3700712417536 3700712417550 3700712417574 3700712410469 3700712410476 3700712410483 3700712410490 3700712410506 3700712410513 3700712410520 3700712410537 3700712415723 3700712415730 3700712415747 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3700712419653 3700712412142 3700712408626 3700712411190 3700712410957 3700712417673 3700712416614 3700712420000 3700712409784 3700712409227 3700712411091 3700712410865 3700712417680 3700712416003 3700712416942 3700712410247 3700712410001 3700712411121 3700712410889 3700712412647 3700712412654 3700712412661 3700712410360 3700712409937 3700712416355 3700712412272 3700712416270 3700712412265 3700712412920 3700712410148 3700712412760 3700712410209 3700712419684 3700712420031 3700712419660 3700712420017 3700712417697 3700712417703 3700712417710 3700712417727 3700712418687 3700712418694 3700712418700 3700712418717 3700712415358 3700712415365 3700712415174 3700712415181 3700712415068 3700712414313 3700712414900 3700712414917 3700712408107 3700712408374 3700712411374 3700712411633 3700712407193 3700712407421 3700712407650 3700712407889 3700712406240 3700712406264 3700712406394 3700712406424 3700712406431 3700712406455 3700712406547 3700712406578 3700712416034 3700712408114 3700712408381 3700712411381 3700712411640 3700712406790 3700712406813 3700712407056 3700712412456 3700712406783 3700712406806 3700712406950 3700712406974 3700712417741 3700712416546 3700712418458 3700712409692 3700712409111 3700712411268 3700712417765 3700712416522 3700712417307 3700712409623 3700712409067 3700712411275 3700712417734 3700712416553 3700712416515 3700712412135 3700712408619 3700712411312 3700712417758 3700712416539 3700712416492 3700712409777 3700712409203 3700712411213 3700712417772 3700712416508 3700712416478 3700712409555 3700712409029 3700712411282 3700712417789 3700712416485 3700712416461 3700712409487 3700712408985 3700712411299 3700712412951 3700712412968 3700712412975 3700712410261 3700712409999 3700712412982 3700712412678 3700712412685 3700712412692 3700712410377 3700712409920 3700712411138 3700712417802 3700712416430 3700712418359 3700712409425 3700712408947 3700712417826 3700712416416 3700712417284 3700712409357 3700712408909 3700712417796 3700712416386 3700712416379 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3700712407896 3700712406233 3700712406196 3700712406325 3700712406332 3700712406363 3700712406387 3700712406554 3700712406561 3700712408121 3700712408398 3700712411398 3700712411657 3700712406844 3700712406868 3700712406622 3700712406646 3700712406820 3700712406837 3700712406998 3700712407018 3700712417864 3700712419592 3700712418465 3700712409678 3700712409104 3700712417888 3700712418489 3700712418496 3700712409166 3700712409050 3700712417857 3700712418472 3700712416454 3700712410322 3700712408602 3700712417871 3700712418540 3700712416447 3700712409760 3700712409197 3700712417895 3700712419950 3700712418656 3700712409548 3700712409012 3700712417901 3700712418304 3700712418311 3700712409463 3700712408978 3700712412999 3700712413002 3700712413019 3700712410278 3700712409982 3700712412708 3700712412715 3700712412722 3700712410407 3700712409913 3700712417925 3700712416423 3700712418342 3700712409401 3700712408930 3700712417949 3700712416409 3700712418427 3700712409340 3700712408893 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3700712412944 3700712412739 3700712412746 3700712410254 3700712409517 3700712412791 3700712416911 3700712419370 3700712421144 3700712414399 3700712414412 3700712414962 3700712414979 3700712407223 3700712407452 3700712407681 3700712407919 3700712406257 3700712406370 3700712406417 3700712406592 3700712408145 3700712408190 3700712408411 3700712408466 3700712411404 3700712411459 3700712411671 3700712411725 3700712406943 3700712406677 3700712406875 3700712407049 3700712411176 3700712410926 3700712418038 3700712419561 3700712417314 3700712409852 3700712409418 3700712411220 3700712410971 3700712419912 3700712419929 3700712409753 3700712409173 3700712411039 3700712410797 3700712413040 3700712413033 3700712413026 3700712410353 3700712410100 3700712411060 3700712410841 3700712413071 3700712413101 3700712413095 3700712410421 3700712410063 3700712419615 3700712418045 3700712416171 3700712416164 3700712416157 3700712416140 3700712419639 3700712419981 3700712419967 3700712418052 3700712418069 3700712418076 3700712418083 3700712418724 3700712418731 3700712418748 3700712418755 3700712418762 3700712418786 3700712418793 3700712418809 3700712414627 3700712414610 3700712415495 3700712414863 3700712407230 3700712407469 3700712407698 3700712407926 3700712412395 3700712412364 3700712412388 3700712412371 3700712408152 3700712408428 3700712411411 3700712411688 3700712419486 3700712419547 3700712419899 3700712419554 3700712419905 3700712419837 3700712419493 3700712419844 3700712418090 3700712418106 3700712418113 3700712418120 3700712418816 3700712418823 3700712418830 3700712418847 3700712418854 3700712418861 3700712418878 3700712418885 3700712419516 3700712419578 3700712419936 3700712419585 3700712419943 3700712419851 3700712419509 3700712419868 3700712418137 3700712418144 3700712418151 3700712418168 3700712418946 3700712418892 3700712418908 3700712418915 3700712418922 3700712418939 3700712418953 3700712407339 3700712407568 3700712407797 3700712408022 3700712408299 3700712408565 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Recalling Firm/
Manufacturer		 Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
For Additional Information ContactJessica Minaya
973-709-7634
Manufacturer Reason
for Recall		A potential for a light system to fall in the operating room.
FDA Determined
Cause 2		Equipment maintenance
ActionAn URGENT MEDICAL DEVICE CORRECTION letter dated 11/8/23 was sent to customers. Actions to be taken by the customer: Our records indicate that you have been identified as having purchased at least one model of one of these product ranges. Please identify your affected units using the referenced devices on page 1 and follow the instructions below. Please distribute this notice and forward the link below to access manuals to anyone within your organization who may need to use the manuals, and especially to your service or service provider who performs your maintenance. Light system fixing and other replacements: Regarding: - the fixing of the light systems: suspensions fixing screws, adapter fixing screws, bushing fixing screws - the brake screws - the safety segments - the batteries, a dedicated instruction to illustrate and facilitate understanding of what to replace and what to order for replacement has been issued. The instruction is available on a dedicated space on the web portal https://www.getinge.com/int/campaigns/maintenance-and-service-on-or-light-system/, and provided upon request by emailing MSA808092.sw@getinge.com Should you have questions or require additional information, please do not hesitate to contact Maquet SAS/Getinge or your local representative. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 7) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to or-lights2023.qrc@getinge.com or by faxing the form to (866) 350-0897. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Maquet SAS / Getinge: As the majority of customers may not have regular contact with Getinge services or authorized Getinge representatives and therefore may not be aware of current maintenance recommendations, Maquet SAS/Getinge is providin
Quantity in Commerce236793 units in total
DistributionUS Nationwide. Global Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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