Maquet PowerLED II ARDPWT209029ARecalls & reported problems
Maquet Sas · PWDII55DF 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
- 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 03700712407407), received between May 16, 2023 and Jul 21, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Leak/Splash1
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.
MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak
ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 500. IT WAS STATED DUE TO THE AIR-CONDITIONING WATER ENTERING THE POWER SUPPLY CABINET, ONE HEADLIGHT TURNED OFF AND SECOND TURNED ON. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17369197 ↗MalfunctionMay 16, 2023Leak/Splash; Leak/Splash
ON 9TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - POWERLED II. INITIALLY IT WAS STATED THE ONE LIGHTHEAD DID NOT WORK. BASED ON ADDITIONAL CLARIFICATION PROVIDED BY THE GETINGE TECHNICIAN, IT WAS ESTABLISHED THAT THE LOCAL ROOM AIR CONDITIONER WAS LEAKING WATER INTO THE CEILING POWER SUPPLY BOX, THERE WAS A WATER INSIDE THE BOX AND POWER SUPPLY BECAME DAMAGED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THAT AFTER HIS VISIT THE AFFECTED DEVICE IS OPERATIONAL AND CAN BE USED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940122 ↗
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- 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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