Maquet PowerLED/HLED and PowerLED300 OR Light Systems
Medical device recall Z-0763-2024. Published in FDA’s Enforcement Report on Jan 24, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 24, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 236793 units in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A potential for a light system to fall in the operating room.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
236793 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All systems affected. UDI-DI: 3700712405847 3700712406134 03700712405977 3700712403133 03700712403140 03700712402259 03700712402266 03700712402273 03700712404277 03700712403232 03700712403454 03700712402471 03700712402488 03700712402495…
Every code shown here, 1,990 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…
FDA’s list runs to 4,434 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide. Global Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 8, 2023.
- FDA classified it on Jan 18, 2024.
- FDA’s Enforcement Report published it on Jan 24, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Getinge Usa Sales Inc, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,434 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.