Maquet PowerLED II ARDPWT229062ARecalls & reported problems
Maquet Sas · PWDII75DF VP AIM CL K3 0810 · Class 2
All models of Maquet PowerLED II (992)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712406066), received between Jul 12, 2023 and May 5, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Crack1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT PAINT WAS CHIPPING OFF ON FORK. 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 25076739 ↗MalfunctionJul 31, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
ON 26TH JUNE, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 500. IT WAS STATED THAT THE HOOD WAS DAMAGED. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER 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 19869784 ↗MalfunctionJul 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE HANDLE OF THE MONITOR CAME OFF DURING SURGERY, THIS EVENT DID NOT CAUSE ANY DELAYS. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305529 ↗
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- Maquet PowerLED II ARDPWT229064AMaquet Sas · Lamp, Surgical1 recall3 reports
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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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