Maquet PowerLEDII OR Light System
Medical device recall Z-0757-2024. 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 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 -
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: 03700712414207 03700712407094 03700712407087 03700712407070 03700712406141 3700712407148 3700712407155 3700712407377 3700712407384 3700712407605 3700712407612 3700712407834 3700712407841 3700712406172…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 29,231 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 29,231 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.