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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93567

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

Open FDA event record

Event summary

Timeline bucket
November 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Getinge Usa Sales Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

15 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 15

Maquet 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 -

Z-0757-2024
Recall number
Z-0757-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

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 3700712415280 3700712414276 3700712414719 3700712415099 3700712415105 3700712415785 3700712413903 3700712414566 3700712415709 3700712421137 3700712415006 3700712415013 3700712414870 3700712414887 3700712415440 3700712415457 3700712414795 3700712414801 3700712407162 3700712407285 3700712407391 3700712407513 3700712407629 3700712407742 3700712407858 3700712407971 3700712406165 3700712406189 3700712406301 3700712406271 3700712406462 3700712406486 3700712406493 3700712406509 3700712419400 3700712408077 3700712408343 3700712411343 3700712411602 3700712406714 3700712406745 3700712406981 3700712407001 3700712406707 3700712406721 3700712406899 3700712406905 3700712417468 3700712419431 3700712418441 3700712409715 3700712409128 3700712417482 3700712418502 3700712418519 3700712409630 3700712409081 3700712417451 3700712416638 3700712416652 3700712412159 3700712408633 3700712417475 3700712416645 3700712416669 3700712409791 3700712409241 3700712417499 3700712419417 3700712418649 3700712409579 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 3700712415754 3700712415310 3700712415327 3700712414733 3700712414740 3700712415136 3700712415143 3700712414573 3700712414580 3700712415020 3700712415037 3700712414689 3700712414672 3700712415464 3700712415471 3700712414818 3700712414825 3700712407292 3700712407520 3700712407759 3700712407988 3700712408251 3700712408527 3700712411510 3700712411787 3700712407308 3700712407537 3700712407766 3700712407995 3700712408268 3700712408534 3700712411527 3700712411794 3700712407179 3700712407278 3700712407407 3700712407506 3700712407636 3700712407735 3700712407865 3700712407964 3700712406202 3700712406295 3700712406516 3700712406523 3700712408084 3700712408169 3700712408350 3700712408435 3700712411350 3700712411428 3700712411619 3700712411695 3700712406752 3700712407025 3700712406738 3700712406929 3700712416560 3700712419646 3700712412173 3700712408657 3700712411305 3700712411015 3700712417598 3700712416577 3700712419998 3700712409814 3700712409302 3700712411206 3700712410964 3700712417604 3700712412562 3700712412593 3700712410216 3700712410025 3700712411084 3700712410872 3700712417611 3700712413286 3700712413293 3700712410339 3700712409951 3700712411114 3700712410896 3700712412630 3700712416393 3700712419677 3700712412296 3700712408763 3700712416324 3700712420024 3700712412449 3700712408756 3700712412845 3700712412852 3700712410186 3700712409685 3700712413187 3700712413170 3700712410308 3700712409562 3700712417628 3700712417635 3700712417642 3700712417659 3700712415334 3700712415341 3700712415150 3700712415167 3700712420154 3700712415044 3700712415051 3700712415488 3700712414894 3700712407186 3700712407261 3700712407414 3700712407490 3700712407643 3700712407728 3700712407872 3700712407957 3700712406219 3700712406318 3700712406356 3700712406530 3700712408091 3700712408176 3700712408367 3700712408442 3700712411367 3700712411435 3700712411626 3700712411701 3700712406776 3700712407032 3700712406769 3700712406936 3700712411152 3700712410902 3700712417666 3700712416607 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 3700712412258 3700712408749 3700712417819 3700712416317 3700712416300 3700712412241 3700712408732 3700712417833 3700712416591 3700712419608 3700712409296 3700712408862 3700712417840 3700712416249 3700712418595 3700712409234 3700712408824 3700712412869 3700712412876 3700712412883 3700712410179 3700712409661 3700712413163 3700712413156 3700712413149 3700712410285 3700712409531 3700712414252 3700712414245 3700712414320 3700712414337 3700712416584 3700712416201 3700712416195 3700712416188 3700712410704 3700712410711 3700712410728 3700712410735 3700712410742 3700712410759 3700712410766 3700712412401 3700712415372 3700712415396 3700712415402 3700712415419 3700712414757 3700712414764 3700712415198 3700712415204 3700712415211 3700712415228 3700712414597 3700712414603 3700712415716 3700712414344 3700712414351 3700712414504 3700712414511 3700712414665 3700712414658 3700712414924 3700712414931 3700712414429 3700712414436 3700712413897 3700712414832 3700712407209 3700712407438 3700712407667 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 3700712416348 3700712416331 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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 3700712411558 3700712411824 3700712407346 3700712407575 3700712407803 3700712408039 3700712408305 3700712408572 3700712411565 3700712411831 3700712407247 3700712407483 3700712407704 3700712407933 3700712408206 3700712408213 3700712408473 3700712408480 3700712411466 3700712411473 3700712411732 3700712411763 3700712411183 3700712410933 3700712418175 3700712419714 3700712419721 3700712409845 3700712409388 3700712411244 3700712410995 3700712418182 3700712420048 3700712420055 3700712409746 3700712409159 3700712411022 3700712410780 3700712413118 3700712413125 3700712413132 3700712410391 3700712410087 3700712411077 3700712410858 3700712413361 3700712413378 3700712413354 3700712410414 3700712410070 3700712419769 3700712418298 3700712419776 3700712412197 3700712408688 3700712418199 3700712420109 3700712420116 3700712412180 3700712408671 3700712413248 3700712413231 3700712413224 3700712410124 3700712409593 3700712412807 3700712412814 3700712412821 3700712409869 3700712409449 3700712420161 3700712407254 3700712407476 3700712407711 3700712407940 3700712408220 3700712408237 3700712408497 3700712408503 3700712411480 3700712411497 3700712411749 3700712411756 3700712411169 3700712410940 3700712418205 3700712419707 3700712419738 3700712409838 3700712409364 3700712411251 3700712411008 3700712418212 3700712420062 3700712420079 3700712409739 3700712409142 3700712411046 3700712410810 3700712418229 3700712416928 3700712416935 3700712410438 3700712410049 3700712411053 3700712410827 3700712413347 3700712413330 3700712413323 3700712410384 3700712410094 3700712419806 3700712419394 3700712419813 3700712419387 3700712419745 3700712420086 3700712419783 3700712420093 3700712419790 3700712418236 3700712419752 3700712418243 3700712418960 3700712418977 3700712418984 3700712418991 3700712419004 3700712419011 3700712419028 3700712419035 3700712408244 3700712408510 3700712411503 3700712411770 3700712419691 3700712422868 3700712421502 3700712422875 3700712422882 3700712422899 3700712422905 3700712422912 3700712422929 3700712422936 3700712422943 3700712422950 3700712422967 3700712422974 3700712422981 3700712422998 3700712423001 3700712423018 3700712423025 3700712423032 3700712423049 3700712423056 3700712423063 3700712423070 3700712423087 3700712423094 3700712423100 3700712423117 3700712423124 3700712423131 3700712423148 3700712423155 3700712423162 3700712423179 3700712423186 3700712423193 3700712423209 3700712423216 3700712423223 3700712423230 3700712423247 3700712423254 3700712423261 3700712423278 3700712423285 3700712423292 3700712423308 3700712423315 3700712423322 3700712423339 3700712423346 3700712423353 3700712423360 3700712423377 3700712423384 3700712421588 3700712423391 3700712423407 3700712423414 3700712423421 3700712423438 3700712423445 3700712423452 3700712423469 3700712423476 3700712423483 3700712423490 3700712423506 3700712423513 3700712423520 3700712423537 3700712423544 3700712423551 3700712423568 3700712423575 3700712423582 3700712423599 3700712423605 3700712423612 3700712423629 3700712423636 3700712423643 3700712423650 3700712423667 3700712423674 3700712423681 3700712423698 3700712423704 3700712423711 3700712423728 3700712423735 3700712423742 3700712423759 3700712423766 3700712423773 3700712423780 3700712423797 3700712423803 3700712423810 3700712423827 3700712423834 3700712423841 3700712423858 3700712423865 3700712423872 3700712423889 3700712423896 3700712423902 3700712423919 3700712423926 3700712423933 3700712423940 3700712423957 3700712423964 3700712423971 3700712423988 3700712423995 3700712424008 3700712424015 3700712424022 3700712424039 3700712424046 3700712424053 3700712424060 3700712424077 3700712424084 3700712424091 3700712424107 3700712424114 3700712424121 3700712424138 3700712424145 3700712424152 3700712424169 3700712424176 3700712424183 3700712424190 3700712424206 3700712424213 3700712424220 3700712424237 3700712424244 3700712424251 3700712424268 3700712424275 3700712424282 3700712424299 3700712424305 3700712424312 3700712424329 3700712424336 3700712424343 3700712424350 3700712424367 3700712424374 3700712424381 3700712424398 3700712424404 3700712424411 3700712424428 3700712424435 3700712424442 3700712424459 3700712424466 3700712424473 3700712424480 3700712424497 3700712424503 3700712424510 3700712424527 3700712424534 3700712424541 3700712424558 3700712424565 3700712424572 3700712424589 3700712424596 3700712424602 3700712424619 3700712424626 3700712424633 3700712424640 3700712424657 3700712424664 3700712424671 3700712421601 3700712424688 3700712424695 3700712424701 3700712424718 3700712424725 3700712424732 3700712424749 3700712424756 3700712424763 3700712424770 3700712424787 3700712424794 3700712424800 3700712424817 3700712424824 3700712424831 3700712424848 3700712424855 3700712424862 3700712424879 3700712424886 3700712424893 3700712424909 3700712424916 3700712424923 3700712424930 3700712424947 3700712424954 3700712424961 3700712424978 3700712424985 3700712424992 3700712425005 3700712425012 3700712425029 3700712425036 3700712425043 3700712425050 3700712425067 3700712425074 3700712425081 3700712425098 3700712425104 3700712425111 3700712425128 3700712425135 3700712425142 3700712425159 3700712425166 3700712425173 3700712425180 3700712425197 3700712425203 3700712425210 3700712425227 3700712425234 3700712425241 3700712425258 3700712425265 3700712425272 3700712425289 3700712425296 3700712425302 3700712425319 3700712425326 3700712425333 3700712425340 3700712425357 3700712425364 3700712425371 3700712425388 3700712425395 3700712425401 3700712425418 3700712425425 3700712425432 3700712425449 3700712425456 3700712425463 3700712425470 3700712425487 3700712425494 3700712425500 3700712425517 3700712425524 3700712425531 3700712425548 3700712425555 3700712425562 3700712425579 3700712425586 3700712425593 3700712425609 3700712425616 3700712425623 3700712425630 3700712425647 3700712425654 3700712425661 3700712425678 3700712425685 3700712425692 3700712425708 3700712425715 3700712425722 3700712425739 3700712425746 3700712425753 3700712425760 3700712425777 3700712425784 3700712425791 3700712425807 3700712425814 3700712425821 3700712425838 3700712425845 3700712425852 3700712425869 3700712425876 3700712425883 3700712425890 3700712425906 3700712425913 3700712425920 3700712425937 3700712425944 3700712425951 3700712425968 3700712425975 3700712425982 3700712425999 3700712426002 3700712426019 3700712426026 3700712426033 3700712426040 3700712426057 3700712426064 3700712426071 3700712426088 3700712426095 3700712426101 3700712426118 3700712426125 3700712426132 3700712426149 3700712426156 3700712426163 3700712426170 3700712426187 3700712426194 3700712426200 3700712426217 3700712426224 3700712426231 3700712426248 3700712426255 3700712426262 3700712426279 3700712426286 3700712426293 3700712426309 3700712426316 3700712426323 3700712426330 3700712426347 3700712426354 3700712426361 3700712426378 3700712426385 3700712426392 3700712426408 3700712426415 3700712426422 3700712426439 3700712426446 3700712426453 3700712426460 3700712426477 3700712426484 3700712426491 3700712426507 3700712426514 3700712426521 3700712426538 3700712426545 3700712426552 3700712426569 3700712426576 3700712426583 3700712426590 3700712426606 3700712426613 3700712426620 3700712426637 3700712421540 3700712426644 3700712426651 3700712426668 3700712426675 3700712426682 3700712426699 3700712426705 3700712426712 3700712426729 3700712426736 3700712426743 3700712426750 3700712426767 3700712426774 3700712426781 3700712426798 3700712426804 3700712432751 3700712426828 3700712426835 3700712426842 3700712426859 3700712426866 3700712426873 3700712426880 3700712426897 3700712426903 3700712426910 3700712426927 3700712426934 3700712426941 3700712426958 3700712426965 3700712426972 3700712426989 3700712426996 3700712427009 3700712427016 3700712427023 3700712427030 3700712427078 3700712427085 3700712427092 3700712427108 3700712427115 3700712427122 3700712427139 3700712427146 3700712427153 3700712427160 3700712427177 3700712427184 3700712427191 3700712427207 3700712427214 3700712427221 3700712427238 3700712427245 3700712427252 3700712427269 3700712427276 3700712427283 3700712427290 3700712427306 3700712427313 3700712427320 3700712427337 3700712427344 3700712427351 3700712427368 3700712427375 3700712427382 3700712427399 3700712427405 3700712427412 3700712427429 3700712427436 3700712427443 3700712427450 3700712427467 3700712427474 3700712427498 3700712427504 3700712427511 3700712427528 3700712427535 3700712427542 3700712427559 3700712427566 3700712427573 3700712427580 3700712427597 3700712427603 3700712427610 3700712427627 3700712427634 3700712427641 3700712427658 3700712427665 3700712427672 3700712427689 3700712427696 3700712427702 3700712427719 3700712427726 3700712427733 3700712427740 3700712427757 3700712421595 3700712427764 3700712427771 3700712427788 3700712427795 3700712427801 3700712427818 3700712427825 3700712427832 3700712427849 3700712427856 3700712427863 3700712427870 3700712427887 3700712427894 3700712427900 3700712427917 3700712427924 3700712427931 3700712427948 3700712427955 3700712427962 3700712427979 3700712427986 3700712427993 3700712428006 3700712428013 3700712428020 3700712428037 3700712428044 3700712428051 3700712428068 3700712428075 3700712428082 3700712428099 3700712428105 3700712428112 3700712428129 3700712428136 3700712428143 3700712428150 3700712428167 3700712428174 3700712428181 3700712428198 3700712428204 3700712428211 3700712428228 3700712428235 3700712428242 3700712428259 3700712428266 3700712428273 3700712428280 3700712428297 3700712428303 3700712428310 3700712428327 3700712428334 3700712428341 3700712428358 3700712428365 3700712428372 3700712428389 3700712428396 3700712428402 3700712428419 3700712428426 3700712428433 3700712428440 3700712428457 3700712428464 3700712428471 3700712428488 3700712428495 3700712428501 3700712428518 3700712428525 3700712428532 3700712428549 3700712428556 3700712428563 3700712428570 3700712428587 3700712428594 3700712428600 3700712428617 3700712428624 3700712428631 3700712428648 3700712428655 3700712428662 3700712428679 3700712428686 3700712428693 3700712428709 3700712428716 3700712428723 3700712428730 3700712428747 3700712428754 3700712428761 3700712428778 3700712428785 3700712428792 3700712428808 3700712428815 3700712428822 3700712428839 3700712428846 3700712428853 3700712428860 3700712428877 3700712428884 3700712428891 3700712428907 3700712428914 3700712428921 3700712428938 3700712421557 3700712428945 3700712428952 3700712428969 3700712428976 3700712428983 3700712428990 3700712429003 3700712429010 3700712429027 3700712429034 3700712429041 3700712429058 3700712429065 3700712429072 3700712429089 3700712429096 3700712429102 3700712429119 3700712429126 3700712429133 3700712429140 3700712429157 3700712429164 3700712429171 3700712429188 3700712429195 3700712429201 3700712429218 3700712429225 3700712429232 3700712429249 3700712429256 3700712429263 3700712429270 3700712429287 3700712429294 3700712429300 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3700712430016 3700712430023 3700712430030 3700712430047 3700712430054 3700712430061 3700712430078 3700712430085 3700712430092 3700712430108 3700712430115 3700712430122 3700712430139 3700712430146 3700712430153 3700712430160 3700712430177 3700712430184 3700712430191 3700712430207 3700712430214 3700712430221 3700712430238 3700712430245 3700712430252 3700712430269 3700712430276 3700712430283 3700712430290 3700712421564 3700712430306 3700712430313 3700712430320 3700712430337 3700712430344 3700712430351 3700712430368 3700712430375 3700712430382 3700712430399 3700712430405 3700712430412 3700712430429 3700712430436 3700712430443 3700712430450 3700712430467 3700712430474 3700712430481 3700712430498 3700712430504 3700712430511 3700712430528 3700712430535 3700712430542 3700712430559 3700712430566 3700712430573 3700712430580 3700712430597 3700712430603 3700712430610 3700712430627 3700712430634 3700712430641 3700712430658 3700712430665 3700712430672 3700712430689 3700712430696 3700712430702 3700712430719 3700712430726 3700712430733 3700712430740 3700712430757 3700712430764 3700712430771 3700712430788 3700712430795 3700712430801 3700712430818 3700712430825 3700712430832 3700712430849 3700712430856 3700712430863 3700712430870 3700712430887 3700712430894 3700712430900 3700712430917 3700712430924 3700712430931 3700712430948 3700712430955 3700712430962 3700712430979 3700712430986 3700712430993 3700712431006 3700712431013 3700712431020 3700712421526 3700712431037 3700712431044 3700712431051 3700712431068 3700712431075 3700712431082 3700712431099 3700712431105 3700712431112 3700712431129 3700712431136 3700712431143 3700712431150 3700712431167 3700712431174 3700712431181 3700712431198 3700712431204 3700712421618 3700712431211 3700712431228 3700712431235 3700712431242 3700712431259 3700712431266 3700712421571 3700712431273 3700712431280 3700712431297 3700712431303 3700712431310 3700712431327 3700712431334 3700712431341 3700712431358 3700712431365 3700712431372 3700712431389 3700712431396 3700712431402 3700712431419 3700712431426 3700712431433 3700712431440 3700712431457 3700712431464 3700712431471 3700712431488 3700712431495 3700712431501 3700712431518 3700712431525 3700712431532 3700712431549 3700712431556 3700712431563 3700712431570 3700712431587 3700712431594 3700712431600 3700712431617 3700712431624 3700712431631 3700712431648 3700712431655 3700712431662 3700712431679 3700712431686 3700712431693 3700712431709 3700712431716 3700712431723 3700712431730 3700712431747 3700712431754 3700712431761 3700712431778 3700712431785 3700712431792 3700712431808 3700712431815 3700712431822 3700712431839 3700712431846 3700712431853 3700712431860 3700712431877 3700712431884 3700712431891 3700712431907 3700712431914 3700712431921 3700712431938 3700712431945 3700712431952 3700712431969 3700712431976 3700712431983 3700712431990 3700712432003 3700712432010 3700712432027 3700712432034 3700712432041 3700712432058 3700712432065 3700712432072 3700712432089 3700712432096 3700712432102 3700712432119 3700712421533 3700712432126 3700712432133 3700712432140 3700712432157 3700712432164 3700712432171 3700712432188 3700712432195 3700712432201 3700712432218 3700712432225 3700712432232 3700712432249 3700712432256 3700712432263 3700712432270 3700712432287 03700712411992 03700712412005 03700712412074 03700712412081 03700712412012 03700712412029 03700712412098 03700712412104

Distribution pattern

US Nationwide. Global Distribution.

device · product 2 of 15

Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, ROL FOR VLT400SF STP - ARDROL309000A, ROL FOR VLT400SF STP - ARDROL309000C, ROL FOR VLT600SF STP - ARDROL309002A, ROL FOR VLT600SF STP - ARDROL309002C, VCS40 ROL - ARDROL309024A, VCS40 ROL - ARDROL309024C, VCS40 ROL - ARDROL309028A, VCS40 ROL - ARDROL309028C, VCS60 ROL - ARDROL309025A, VCS60 ROL - ARDROL309025C, VCS60 ROL - ARDROL309029A, VCS60 ROL - ARDROL309029C, VST40 - ARDROL309016A, VST40 - ARDROL309016C, VST40 - ARDROL309017A, VST40 - ARDROL309017C, VST40 - ARDROL309020A, VST40 - ARDROL309020C, VST40 - ARDROL309022A, VST40 - ARDROL309022C, VST60 - ARDROL309018A, VST60 - ARDROL309018C, VST60 - ARDROL309019A, VST60 - ARDROL309019C, VST60 - ARDROL309021A, VST60 - ARDROL309021C, VST60 - ARDROL309023A, VST60 - ARDROL309023C, VCS40DF - ARDVCS209001A, VCS40DF - ARDVCS209001C, VCS40DF - ARDVCS209010A, VCS40DF - ARDVCS209012A, VCS40DF - ARDVCS209021A, VCS40SF - ARDVCS209000A, VCS40SF - ARDVCS209000C, VCS40SF - ARDVCS209011A, VCS40SF 08 - ARDVCS209046A, VCS44DF - ARDVCS209005A, VCS44DF - ARDVCS209005C, VCS44DF - ARDVCS209016A, VCS44SF - ARDVCS209004A, VCS44SF - ARDVCS209004C, VCS44SF - ARDVCS209015A, VCS44SFDF - ARD2VCS00040A, VCS60DF - ARDVCS209003A, VCS60DF - ARDVCS209003C, VCS60DF - ARDVCS209014A, VCS60DF - ARDVCS209022A, VCS60DF 11 - ARDVCS209047A, VCS60SF - ARDVCS209002A, VCS60SF - ARDVCS209002C, VCS60SF - ARDVCS209013A, VCS64DF - ARDVCS209007A, VCS64DF - ARDVCS209007C, VCS64DF - ARDVCS209018A, VCS64SF - ARDVCS209006A, VCS64SF - ARDVCS209006C, VCS64SF - ARDVCS209017A, VCS64SFDF - ARD2VCS00010A, VCS64SFDF 1011 - ARDVCS209048A, VCS66DF - ARDVCS209009A, VCS66DF - ARDVCS209009C, VCS66DF - ARDVCS209020A, VCS66SF - ARDVCS209008A, VCS66SF - ARDVCS209008C, VCS66SF - ARDVCS209019A, VCSII40DF SB08 - ARDVCS209023A, VCSII40DF SB11 - ARDVCS209024A, VCSII40SF SB11 - ARDVCS209025A, VCSII44DF SB0810 - ARDVCS209026A, VCSII44SF SB1011 - ARDVCS209027A, VCSII60DF SB08 - ARDVCS209028A, VCSII60SF SB11 - ARDVCS209029A, VCSII64DF SB0810 - ARDVCS209030A, VCSII64SF SB1011 - ARDVCS209031A, VCSII66DF SB0810 - ARDVCS209032A, VCSII66SF SB1011 - ARDVCS209033A, VCSII40DF TK SB08 - ARDVCS209034A, VCSII40DF TK SB11 - ARDVCS209035A, VCSII40SF TK SB11 - ARDVCS209036A, VCSII44DF TK SB0810 - ARDVCS209037A, VCSII44SF TK SB1011 - ARDVCS209038A, VCSII60DF TK SB08 - ARDVCS209039A, VCSII60SF TK SB11 - ARDVCS209040A, VCSII64DF TK SB0810 - ARDVCS209041A, VCSII64SF TK SB1011 - ARDVCS209042A, VCSII66DF TK SB0810 - ARDVCS209043A, VCSII66SF TK SB1011 - ARDVCS209044A, VCS40DF SAT 12 - ARD2VCS00070A, VCSII40SF SB08 - ARDVCS209049A, VCSII64SFDF SB1011 - ARDVCS209050A, SAT VLT400D - ARD2SAT00080C, SAT VLT400D - ARD2SAT00100C, SAT VLT400DF - ARD2SAT00080A, SAT VLT400DF - ARD2SAT00100A, SAT VLT400S - ARD2SAT00030C, SAT VLT400S - ARD2SAT00040C, SAT VLT400SF - ARD2SAT00040A, SAT VLT40DF - ARD268800130A, SAT VLT40DF - ARD268800130C, SAT VLT40SF - ARD268800120A, SAT VLT40SF - ARD268800120C, SAT VLT60DF - ARD2SAT00170A, SAT VLT60DF - ARD2SAT00170C, SAT VLT60SF - ARD2SAT00180C, SAT VST40DF - ARDSAT209018A, SAT VST40DF - ARDSAT209019A, SAT VST40DF - ARDSAT209022A, SAT VST40DF - ARDSAT209023A, SAT VST40SF - ARDSAT209010A, SAT VST40SF - ARDSAT209011A, SAT VST40SF - ARDSAT209014A, SAT VST40SF - ARDSAT209015A, SAT VST60DF - ARDSAT209034A, SAT VST60DF - ARDSAT209035A, SAT VST60DF - ARDSAT209038A, SAT VST60DF - ARDSAT209039A, SAT VST60SF - ARDSAT209026A, SAT VST60SF - ARDSAT209027A, SAT VST60SF - ARDSAT209030A, SAT VST60SF - ARDSAT209031A, STANDOP 40DF SINGLE - ARDSTP229005A, STANDOP 40SF SINGLE - ARDSTP229000A, STANDOP 44DF DOUBLE - ARDSTP229007A, STANDOP 44SF DOUBLE - ARDSTP229002A, STANDOP 60DF SINGLE - ARDSTP229006A, STANDOP 60SF SINGLE - ARDSTP229001A, STANDOP 64DF DOUBLE - ARDSTP229008A, STANDOP 64SF DOUBLE - ARDS

Z-0758-2024
Recall number
Z-0758-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected UDI-DI: 03700712400798 03700712400804 03700712400811 03700712400828 03700712400835 03700712400842 03700712400859 03700712400866 03700712400873 03700712400880 03700712400897 03700712400903

Distribution pattern

US Nationwide. Global Distribution.

device · product 3 of 15

Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDLCA209008A, LCA 10 - ARDLCA209008C, LCA 10 - ARDLCA209009A, LCA 10 - ARDLCA209009C, LCA 10 - ARDLCA209010A, LCA 10 - ARDLCA209010C, LCA 10 - ARDLCA409000C, LCA 10 - ARDLCA409001C, LCA 10 - ARDLCA409002A, LCA 10 - ARDLCA409002C, LCA 10 - ARDLCA409003C, LCA 10 - ARDLCA409004A, LCA 10 - ARDLCA409004C, LCA 10 - ARDLCA409005C, LCA 10 DES - ARDLCA409001A, LCA 10 MOBILE - ARDLCA309008A, LCA 10 RAIL - ARDLCA409005A, LCA 10 WALL - ARDLCA109006A, LCA 40 - ARDLCA109001C, LCA 40 - ARDLCA208000A, LCA 40 - ARDLCA208000C, LCA 40 - ARDLCA208001A, LCA 40 - ARDLCA208001C, LCA 40 - ARDLCA209000A, LCA 40 - ARDLCA209000C, LCA 40 - ARDLCA209001A, LCA 40 - ARDLCA209001C, LCA 40 - ARDLCA209002A, LCA 40 - ARDLCA209002C, LCA 40 - ARDLCA209003A, LCA 40 - ARDLCA209003C, LCA 40 - ARDLCA209014A, LCA 40 - ARDLCA209014C, LCA 40 - ARDLCA209017A, LCA 40 - ARDLCA209017C, LCA 40 - ARDLCA209018A, LCA 40 - ARDLCA209018C, LCA 40 - ARDLCA209019A, LCA 40 - ARDLCA209019C, LCA 40 - ARDLCA209020A, LCA 40 - ARDLCA209020C, LCA 40 - ARDLCA209021A, LCA 40 - ARDLCA209021C, LCA 40 MOBILE - ARDLCA309009A, LCA 40 WALL - ARDLCA109001A, LCA 40GS - ARDLCA109009A, LCA 40GS - ARDLCA109009C, LCA 100 - ARDLCA109005A, LCA 100 - ARDLCA109005C, LCA 100 - ARDLCA219000A, LCA 100 MOBILE - ARDLCA309006A, LCA 100 MOBILE B - ARDLCA309007A, LCA 100 SAT - ARDSAT209004A, LCA 100 SAT - ARDSAT209005A, LCA 100 V - ARDLCA219000C, LCA 100DF - ARDLCA109008A, LCA 100DF - ARDLCA109008C, LCA 100DF - ARDLCA219003A, LCA 100DF - ARDSAT209008A, LCA 100DF - ARDSAT209009A, LCA 100DF V - ARDLCA219003C, LCA 50 - ARDLCA109004A, LCA 50 - ARDLCA109004C, LCA 50 - ARDLCA209012A, LCA 50 - ARDLCA209012C, LCA 50 - ARDSAT209002A, LCA 50 MOBILE - ARDLCA309004A, LCA 50 MOBILE B - ARDLCA309005A, LCA 50 SAT - ARDSAT209003A, LCA 50 WALL 11 - ARD2LCA00140A, LCA 50DF - ARDLCA109007A, LCA 50DF - ARDLCA109007C, LCA 50DF - ARDLCA209015A, LCA 50DF - ARDLCA209015C, LCA 50DF - ARDSAT209006A, LCA 50DF - ARDSAT209007A, LCA DUO 100 - ARDLCA219001A, LCA DUO 100 V - ARDLCA219001C, LCA DUO 100+50 - ARDLCA219002A, LCA DUO 100+50 V - ARDLCA219002C, LCA DUO 100+50DF - ARDLCA219005A, LCA DUO 100+50DF V - ARDLCA219005C, LCA DUO 100DF - ARDLCA219004A, LCA DUO 100DF V - ARDLCA219004C, LCA DUO 50 - ARDLCA209013A, LCA DUO 50 - ARDLCA209013C, LCA DUO 50DF - ARDLCA209016A, LCA DUO 50DF - ARDLCA209016C, LCA100 MOBILE UPGRADE - ARDLCA506006A, LCA100 UPGRADE - ARDLCA506004A, LCA100 UPGRADE 24V - ARDLCA506005A, LCA100 WALL UPGRADE - ARDLCA506007A, LCA50 UPGRADE - ARDLCA506000A, LCA50 UPGRADE 24V - ARDLCA506001A, LCA50 UPGRADE WALL MOUNTED - ARDLCA506003A, SAT LCA 100 - ARDSAT209004C, SAT LCA 100 - ARDSAT209005C, SAT LCA 100DF - ARDSAT209008C, SAT LCA 100DF - ARDSAT209009C, SAT LCA 50 - ARDSAT209002C, SAT LCA 50 - ARDSAT209003C, SAT LCA 50DF - ARDSAT209006C, SAT LCA 50DF - ARDSAT209007C, LCA 10 MOB - ARDLCA309000A, LCA 10 MOB - ARDLCA309000C, LCA 10 MOB - ARDLCA309002A, LCA 10 MOB - ARDLCA309002C, LCA 10 MOB - ARDLCA309008C, LCA 100 MOBILE - ARDLCA309006C, LCA 100 MOBILE B - ARDLCA309007C, LCA 40 MOB - ARDLCA309001A, LCA 40 MOB - ARDLCA309001C, LCA 40 MOB - ARDLCA309003A, LCA 40 MOB - ARDLCA309003C, LCA 40 MOB - ARDLCA309009C, LCA 40GS MOBILE - ARDLCA309010A, LCA 40GS MOBILE - ARDLCA309010C, LCA 50 MOBILE - ARDLCA309004C, LCA 50 MOBILE B - ARDLCA309005C,

Z-0759-2024
Recall number
Z-0759-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected UDI-DI: 3700712415921 3700712415853 3700712415846 3700712415877 3700712415938 3700712415860 3700712400750 3700712400613 3700712400712 3700712400729 3700712401115 3700712401122 03700712400767 3700712400620 3700712401139 3700712401146 3700712400774 3700712400637 3700712401153 3700712400736 3700712400743 3700712401160 03700712400781 3700712400644 3700712401177 3700712401184 3700712400651 3700712400668 3700712400675 3700712400682 3700712400699 03700712400705 03700712404710 03700712404697 03700712404703 03700712404727 03700712404666 03700712404673 03700712404680

Distribution pattern

US Nationwide. Global Distribution.

device · product 4 of 15

Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015A, ROL PWDII70SF - ARDPWT309016A, ROL VCS40SF - ARDROL309031A, ROL VCS60SF - ARDROL309032A, ROL VST40SF - ARDROL309033A, ROL VST40SF - ARDROL309034A, ROL VST40SF B - ARDROL309037A, ROL VST60SF - ARDROL309035A, ROL VST60SF - ARDROL309036A, ROL VST60SF B - ARDROL309038A, ROL VCSII40SF - ARDROL309039A, ROL VCSII40SF - ARDROL309040A, ROL VCSII60SF - ARDROL309041A, ROL VCSII60SF - ARDROL309042A, ROL PWDII50SF - ARDROL309043A, ROL PWDII50SF - ARDROL309044A, ROL PWDII70SF - ARDROL309045A, ROL PWDII70SF - ARDROL309046A, ROL PWDII50SF - ARDROL309047A, ROL PWDII50SF - ARDROL309048A, ROL PWDII70SF - ARDROL309049A, ROL PWDII70SF - ARDROL309050A, ROL VSTII40SF - ARDROL309051A, ROL VSTII60SF - ARDROL309052A, ROL VSTII40SF - ARDROL309053A, ROL VSTII60SF - ARDROL309054A

Z-0760-2024
Recall number
Z-0760-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected UDI-DI: 3700712411978 3700712411985 3700712412050 3700712412067 3700712412036 3700712412043 3700712412111 3700712412128 3700712417062 3700712417079 3700712417086 3700712417093 3700712419240 3700712417109 3700712417116 3700712419257 3700712422707 3700712422714 3700712422721 3700712422738 3700712422745 3700712422752 3700712422769 3700712422776 3700712422783 3700712422790 3700712422806 3700712422813 3700712422820 3700712422837 3700712422844 3700712422851

Distribution pattern

US Nationwide. Global Distribution.

device · product 5 of 15

Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X

Z-0761-2024
Recall number
Z-0761-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected UDI-DI: 03700712400583 03700712400606 03700712400590 3700712401252 3700712401269 3700712414184 3700712411855 3700712411862 3700712420208 3700712415778 3700712417123 3700712411916 3700712411923 3700712415822 3700712414177 3700712417154 3700712417161 3700712411879 3700712411886 3700712414160 3700712417130 3700712417147 3700712411893 3700712411909 3700712401092 3700712401108 03700712405946 3700712416829 3700712416805 3700712416812 3700712421076 3700712421083 3700712421090 3700712421106 3700712417253 3700712417260 3700712417277 3700712417239 3700712417246 03700712417031 3700712420130 03700712417048 3700712416072 3700712416997 3700712417000 3700712416126 3700712416119 3700712420147 3700712416065 3700712417017 3700712417024 3700712416096 3700712416102 3700712414306 3700712414283 3700712414290 3700712400972 3700712400989 3700712400996 3700712401009 03700712401016 3700712401023 3700712401030 3700712401047 03700712401078 03700712401085 3700712401191 3700712401207 03700712417178 3700712401276 3700712419349 3700712401283 3700712400057 3700712401221 03700712405915 03700712405908 3700712400132 3700712401245 03700712406073 03700712406059 3700712401054 3700712420178 3700712401061 3700712406042 3700712422240 3700712422257 3700712422264 3700712421427 3700712422271 3700712422288 3700712421403 3700712422295 3700712422301 3700712422318 3700712422325 3700712422332 3700712422349 3700712422356 3700712422363 3700712422370 3700712421441 3700712422387 3700712422394 3700712421465 3700712422400 3700712422417 3700712421496 3700712422424 3700712421472 3700712422431 3700712422448 3700712421489 3700712422455 3700712422462 3700712422479 3700712421410 3700712422486 3700712422493 3700712422509 3700712421458 3700712421434 3700712422516 3700712422523 3700712422530 3700712422547 3700712422554 3700712422561 3700712422578 3700712422585 3700712422592

Distribution pattern

US Nationwide. Global Distribution.

device · product 6 of 15

Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - ARD568803968, OHDII FHD QL+ VP01 - ARD569204944, OHDII AIR03 QL FHD E - ARD568803951

Z-0762-2024
Recall number
Z-0762-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected UDI-DI: 3700712415761 3700712415976 3700712418274 3700712418281 3700712412340

Distribution pattern

US Nationwide. Global Distribution.

device · product 7 of 15

Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS MB3 - ARDINT059003A, EPS MB3 - ARDINT059003C, EPS MB3 TR - ARDINT059001A, EPS MB3 TR - ARDINT059001C, OPT MBAT - ARD568210010A, OPT MBAT - ARD568210010C, PWD30 DUAL - ARD267800310C, PWD30 DUAL - ARD267800330A, PWD30 DUAL - ARD267800330C, PWD30 DUAL - ARD267800340A, PWD30 DUAL - ARD267800340C, PWD30+DF - ARD268300170A, PWD30+DF - ARD568424110A, PWD30+DF - ARD568424110C, PWD30+DF - ARD568424114A, PWD30+DF - ARD568424114C, PWD30+DF - ARD568424511A, PWD30+DF - ARD568424511C, PWD30+DF - ARD568424512A, PWD30+DF - ARD568424512C, PWD30+DF - ARD568424513A, PWD30+DF - ARD568424513C, PWD30+DF - ARD568484114A, PWD30+DF - ARD568484114C, PWD30+DF - ARD569424110A, PWD30+DF - ARD569424110C, PWD30+DF - ARD569424114A, PWD30+DF - ARD569424114C, PWD30+DF - ARD569424511A, PWD30+DF - ARD569424511C, PWD30+DF - ARD569424512A, PWD30+DF - ARD569424512C, PWD30+DF - ARD569424513A, PWD30+DF - ARD569424513C, PWD30+DF - ARD569484114A, PWD30+DF - ARD569484114C, PWD30+DF - ARDPWD208008A, PWD30+DF - ARDPWD208008C, PWD30+DF - ARDPWD209000A, PWD30+DF - ARDPWD209000C, PWD30+DF - ARDPWD209009A, PWD30+DF - ARDPWD209009C, PWD30+DF - ARDPWD239013A, PWD30+DF - ARDPWD239013C, PWD30+DF - ARDPWD239014A, PWD30+DF - ARDPWD239014C, PWD30+DF - ARDPWD239015A, PWD30+DF - ARDPWD239015C, PWD30+DF - ARDPWD239031A, PWD30+DF - ARDPWD239031C, PWD30+DF - ARDPWD239032A, PWD30+DF - ARDPWD239032C, PWD30+DF - ARDPWD239033A, PWD30+DF - ARDPWD239033C, PWD30+SF - ARD568414110A, PWD30+SF - ARD568414110C, PWD30+SF - ARD568414114A, PWD30+SF - ARD568414114C, PWD30+SF - ARD568414511A, PWD30+SF - ARD568414511C, PWD30+SF - ARD568414512A, PWD30+SF - ARD568414512C, PWD30+SF - ARD568414513A, PWD30+SF - ARD568414513C, PWD30+SF - ARD568474114A, PWD30+SF - ARD568474114C, PWD30+SF - ARD569414110A, PWD30+SF - ARD569414110C, PWD30+SF - ARD569414114A, PWD30+SF - ARD569414114C, PWD30+SF - ARD569414511A, PWD30+SF - ARD569414511C, PWD30+SF - ARD569414512A, PWD30+SF - ARD569414512C, PWD30+SF - ARD569414513A, PWD30+SF - ARD569414513C, PWD30+SF - ARD569474114A, PWD30+SF - ARD569474114C, PWD30+SF - ARDPWD208009A, PWD30+SF - ARDPWD208009C, PWD30+SF - ARDPWD209001A, PWD30+SF - ARDPWD209001C, PWD30+SF - ARDPWD209002A, PWD30+SF - ARDPWD209002C, PWD30+SF - ARDPWD209010A, PWD30+SF - ARDPWD209010C, PWD30+SF - ARDPWD209011A, PWD30+SF - ARDPWD209011C, PWD30+SF - ARDPWD239016A, PWD30+SF - ARDPWD239016C, PWD30+SF - ARDPWD239017A, PWD30+SF - ARDPWD239017C, PWD30+SF - ARDPWD239018A, PWD30+SF - ARDPWD239018C, PWD30+SF - ARDPWD239034A, PWD30+SF - ARDPWD239034C, PWD30+SF - ARDPWD239035A, PWD30+SF - ARDPWD239035C, PWD30+SF - ARDPWD239036A, PWD30+SF - ARDPWD239036C, PWD30+SHIP - ARD268400080A, PWD30+SHIP - ARD268400080C, PWD33 S - ARD267800200A, PWD33 S - ARD267800200C, PWD33+DF - ARD568424710A, PWD33+DF - ARD568424710C, PWD33+DF - ARD568424714A, PWD33+DF - ARD568424714C, PWD33+DF - ARD568424751A, PWD33+DF - ARD568424751C, PWD33+DF - ARD568424752A, PWD33+DF - ARD568424752C, PWD33+DF - ARD568424753A, PWD33+DF - ARD568424753C, PWD33+DF - ARD568424755A, PWD33+DF - ARD568424755C, PWD33+DF - ARD568424758A, PWD33+DF - ARD568424758C, PWD33+DF - ARD569424710A, PWD33+DF - ARD569424710C, PWD33+DF - ARD569424714A, PWD33+DF - ARD569424714C, PWD33+DF - ARD569424751A, PWD33+DF - ARD569424751C, PWD33+DF - ARD569424752A, PWD33+DF - ARD569424752C, PWD33+DF - ARD569424753A, PWD33+DF - ARD569424753C, PWD33+DF - ARD569424755A, PWD33+DF - ARD569424755C, PWD33+DF - ARD569424758A, PWD33+DF - ARD569424758C, PWD33+SF - ARD568414710A, PWD33+SF - ARD568414710C, PWD33+SF - ARD568414714A, PWD33+SF - ARD568414714C, PWD33+SF - ARD568414751A, PWD33+SF - ARD568414751C, PWD33+SF - ARD568414752A, PWD33+SF - ARD568414752C, PWD33+SF - ARD568414753A, PWD33+SF - ARD568414753C, PWD33+SF - ARD568414755A, PWD33+SF - ARD568414755C, PWD33+SF - ARD568414758A, PWD33+SF - ARD5684147

Z-0763-2024
Recall number
Z-0763-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected. UDI-DI: 3700712405847 3700712406134 03700712405977 3700712403133 03700712403140 03700712402259 03700712402266 03700712402273 03700712404277 03700712403232 03700712403454 03700712402471 03700712402488 03700712402495 3700712403010 03700712403027 03700712403744 03700712403751 03700712403768 3700712403478 03700712403249 03700712403256 03700712403263 03700712402501 03700712402518 03700712402525 ¿3700712406103 03700712403157 03700712403164 03700712403942 03700712403959 03700712403966 03700712403034 03700712403041 03700712403775 03700712403782 03700712403799 03700712403805 03700712405779 03700712403065 03700712403072 03700712402136 03700712402143 03700712402150 03700712402570 03700712401856 03700712401863 03700712401870 03700712402655 03700712403461 03700712403393 03700712406011 03700712402778 03700712402426 03700712402433 03700712402440 03700712402044 03700712402051 03700712402068 03700712402945 03700712402952 03700712403539 03700712403546 03700712403553 03700712402549 03700712402662 03700712403270 03700712403287 03700712411947 03700712402785 03700712402792 03700712402358 03700712402457 03700712402464 03700712404376 03700712401979 03700712402075 03700712402082 03700712403089 03700712403096 03700712402167 03700712402174 03700712403836 03700712403843 03700712402587 03700712401887 03700712401894 03700712402693 03700712403386 03700712402853 03700712404413 03700712402969 03700712402976 03700712403560 03700712403577 03700712403584 03700712403591 03700712402556 03700712402686 03700712403379 03700712402839 03700712402747 03700712403058 03700712402112 03700712402129 03700712403812 03700712403829 03700712402563 03700712401832 03700712401849 03700712414153 03700712403362 03700712404314 03700712402860 03700712402938 03700712403492 03700712403508 03700712403515 03700712403522 03700712402532 03700712402709 03700712403355 03700712404345 03700712402846 03700712404390 03700712402877 03700712404284 03700712405762 03700712403119 03700712402204 03700712402211 03700712402228 03700712403218 03700712404192 03700712404208 03700712402327 03700712402631 03700712401924 03700712401931 03700712401948 03700712403294 03700712403409 03700712403485 03700712405823 03700712406028 03700712405830 03700712402808 03700712402907 03700712402365 03700712402372 03700712402389 03700712401986 03700712401993 03700712402006 03700712402990 03700712403690 03700712403706 03700712403713 03700712403188 03700712404062 03700712404079 03700712404086 03700712402600 03700712402679 03700712403300 03700712403317 03700712403324 03700712403430 03700712411954 03700712402815 03700712402822 03700712402396 03700712402402 03700712402419 03700712404383 03700712402013 03700712402020 03700712402037 03700712403126 03700712402235 03700712402242 03700712403928 03700712403935 03700712403225 03700712402334 03700712402341 03700712404215 03700712404222 03700712402648 03700712401955 03700712401962 03700712402914 03700712403003 03700712402099 03700712402105 03700712403720 03700712403737 03700712403195 03700712402280 03700712402297 03700712404093 03700712404109 03700712402617 03700712402723 03700712402716 03700712403416 03700712403423 03700712402754 03700712402921 03700712403102 03700712402181 03700712402198 03700712403850 03700712403867 03700712403201 03700712402303 03700712402310 03700712404123 03700712404130 03700712402624 03700712401900 03700712401917 03700712413385 03700712403348 03700712404307 03700712404352 03700712402891 03700712404406 03700712402983 03700712403607 03700712403614 03700712403621 03700712403638 03700712403171 03700712403973 03700712403980 03700712403997 03700712404000 03700712402594 03700712403331 03700712404338 03700712402884 03700712402730 03700712403447 03700712402761 03700712403874 03700712403881 03700712403898 03700712403904 03700712403911 03700712404147 03700712404154 03700712404161 03700712404178 03700712404185 03700712404239 03700712404246 03700712404253 03700712404260 03700712404291 03700712403645 03700712403652 03700712403669 03700712403676 03700712403683 03700712404017 03700712404024 03700712404031 03700712404048 03700712404055 03700712404116 03700712404321 03700712404369 03700712404451 03700712404499 03700712404444 03700712404482 03700712404437 03700712404475 03700712404420 03700712404468 03700712404529 03700712404536 03700712404567 03700712404574 03700712404505 03700712404512 03700712404543 03700712404550 03700712413392 03700712401795 03700712401801 03700712401818 03700712401825

Distribution pattern

US Nationwide. Global Distribution.

device · product 8 of 15

Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD567501960A, AXL 5501 - ARD567501960C, AXL 5501S - ARD567505960C, AXL+5001 DF - ARD567502961C, AXL+5001 SF - ARD567502861C, AXL+5301 DF - ARD567502971C, AXL+5501 DF - ARD567502960C, AXL+5501 SF - ARD567502860C, AXL+5531 DF - ARD567502930C, AXL50 RLC - ARDRLC309000C, AXL50 RLC - ARDRLC309006C, AXL5003 - ARD567505968C, AXL5003 US - ARD567505969C

Z-0764-2024
Recall number
Z-0764-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 9 of 15

Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C

Z-0765-2024
Recall number
Z-0765-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 10 of 15

Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, X10AXL+ DF - ARD568211710C, X10AXLDUO - ARD568211000C, X10DF - ARD568211110C, X10DF DUO - ARD568211210C, X10DF DUO - ARD568213410C, X10DF DUO - ARD568223510C, X10DF DUO - ARD568224491C, X10DF DUO - ARD568224492C, X10DF DUO - ARD568224493C, X10DF LD - ARD568213110C, X10DF LD X - ARD568223912C, X10DF LD X - ARD568223913C, X10DF V - ARD568224110C, X10DF V XD - ARD568224912C, X10DF V XS - ARD568224911C, X10DF V XS - ARD568224913C, X10LDAXL+ - ARD568213710C, X10LDAXL+ - ARD568243710C, X10SF - ARD568231110C, X10SF - ARD568244911C, X10SF DUO - ARD568231210C, X10SF DUO - ARD568233410C, X10SF DUO - ARD568243510C, X10SF DUO - ARD568244491C, X10SF DUO - ARD568244492C, X10SF DUO - ARD568244493C, X10SF LD - ARD568233110C, X10SF LD X - ARD568243911C, X10SF TRIO - ARD568244440C, X10SF V - ARD568244110C, X10VAXL+ D - ARD568224710C, X10VAXL+ D - ARD568224791C, X10VAXL+ D - ARD568224792C, X10VAXL+ SF - ARD568244710C, X10VAXL+ SF - ARD568244791C, X10VAXL+ SF - ARD568244792C

Z-0766-2024
Recall number
Z-0766-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 11 of 15

Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C

Z-0767-2024
Recall number
Z-0767-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 12 of 15

Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C

Z-0768-2024
Recall number
Z-0768-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 13 of 15

Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C

Z-0769-2024
Recall number
Z-0769-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 14 of 15

Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113A

Z-0770-2024
Recall number
Z-0770-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.

device · product 15 of 15

Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.

Z-0771-2024
Recall number
Z-0771-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A potential for a light system to fall in the operating room.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A potential for a light system to fall in the operating room.

Code information

All systems affected

Distribution pattern

US Nationwide. Global Distribution.