Reported Jan 24, 2024 · Ongoing
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS…
Getinge USA Sales Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035
Is this the product you have?
- 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
- Lot codes and dates
- All systems affected
- UDI-DI¿3700712406103
37007124058473700712406134037007124059773700712403133037007124031400370071240225903700712402266037007124022730370071240427703700712403232037007124034540370071240247103700712402488037007124024953700712403010037007124030270370071240374403700712403751037007124037683700712403478037007124032490370071240325603700712403263037007124025010370071240251803700712402525
267 of 267 codes
037007124031570370071240316403700712403942037007124039590370071240396603700712403034037007124030410370071240377503700712403782037007124037990370071240380503700712405779037007124030650370071240307203700712402136037007124021430370071240215003700712402570037007124018560370071240186303700712401870037007124026550370071240346103700712403393037007124060110370071240277803700712402426037007124024330370071240244003700712402044037007124020510370071240206803700712402945037007124029520370071240353903700712403546037007124035530370071240254903700712402662037007124032700370071240328703700712411947037007124027850370071240279203700712402358037007124024570370071240246403700712404376037007124019790370071240207503700712402082037007124030890370071240309603700712402167037007124021740370071240383603700712403843037007124025870370071240188703700712401894
- Amount recalled
- 236793 units in total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
A potential for a light system to fall in the operating room.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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