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FDAFDA · Food and drugs·Recall number Z-0763-2024

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

Published January 24, 2024 · Recall initiated: November 8, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Getinge Usa Sales Inc
Distributor
US Nationwide. Global Distribution.
Lot
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 0370071
Risk classification
Class II
Area (FDA)
device
Country
United States

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