Maquet PowerLED II ARDPWT209006ARecalls & reported problems
Maquet Sas · PWDII55SF AIM K3 1011 · Class 2
All models of Maquet PowerLED II (992)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712407186), received between Jul 3, 2024 and Dec 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack2
- Detachment of Device or Device Component2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Crack; Peeled/Delaminated; Detachment of Device or Device Component; Crack; Peeled/Delaminated; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS PEELING FROM FORK AND HANDLE, KEYPAD MEMBRANE WAS DAMAGED AND HEADLIGHT COVERS WERE DAMAGED WITH MISSING PARTICLES. THE ISSUES WERE FOUND DURING PREVENTIVE MAINTENANCE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20841674 ↗MalfunctionJul 3, 2024Crack; Peeled/Delaminated; Detachment of Device or Device Component; Crack; Peeled/Delaminated; Detachment of Device or Device Component
ON 24TH JUNE, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 500. IT WAS STATED THE PAINT WAS DAMAGED ON BRACKET AND SLEEVE. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON FORK AND ARM'S SLEEVE, ALSO KEYPAD MEMBRANE ON FORK WAS CRACKED WITH MISSING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19664333 ↗
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- Maquet PowerLED II ARDPWT229064AMaquet Sas · Lamp, Surgical1 recall3 reports
- Maquet PowerLED II ARDPWT209058AMaquet Sas · Lamp, surgical1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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