Skip to content

Maquet PowerLED/HLED and PowerLED300 OR Light Systems… recallZ-0763-2024 · Getinge Usa Sales Inc · initiated Nov 8, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Getinge Usa Sales Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Equipment maintenance

What the company is doing

An 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 [email protected] 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 [email protected] 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

Recall details

Recall number
Z-0763-2024
Status
Open, Classified
Initiated by the company
Nov 8, 2023
Posted by the FDA
Jan 19, 2024
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total
Product code
FSY
FDA submissions
K070442
Distribution
US Nationwide. Global Distribution.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (6k characters)

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

Devices named in this recall

281 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.

Product lines

Other devices under the same FDA submission

24 devices cleared under K070442 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93567).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page