Maquet PowerLED II ARDPWT229035ARecalls & reported problems
Maquet Sas · PWDII75DF VP AIM K4 0810 · Class 2
All models of Maquet PowerLED II (992)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712408404), received between Jan 5, 2023 and Jan 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Misassembled” (1 report).
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.
Most reported problems
Device problems
- Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2023Misassembled; Misassembled
ON 3RD JANUARY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE SUPPORT WHERE THE DEVICE IS ANCHORED SHOWED FATIGUE IN THE WELDING TO THE STRUCTURE, CAUSING THE UNEVEN CONNECTION. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THIS UNEVEN CONNECTION COULD LEAD TO FALL OF THE DEVICE AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16101344 ↗
Other Lamp, surgical devices
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- ROLITE VOLISTA STANDOP ARDROL309018AMaquet Sas · Lamp, surgical2 recalls0 reports
- Maquet PowerLED II ARDPWT259215AMaquet Sas · Lamp, surgical1 recall30 reports
- iLED7 Surgical Light 4068310Baxter Medical Systems GmbH + Co. KG · Lamp, surgical1 recall5 reports
- Maquet PowerLED II ARDPWT629089AMaquet Sas · Lamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT259043AMaquet Sas · Lamp, surgical1 recall3 reports
- 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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