Maquet PowerLED II ARDPWT229008ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712408138), received between Sep 5, 2023 and Jun 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM HEADLIGHT HANDLE. 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 22224274 ↗
• MalfunctionJun 17, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM HEADLIGHT HANDLE. 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 22217977 ↗
• MalfunctionSep 5, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility; Fluid/Blood Leak; Detachment of Device or Device Component; Device Contaminated at the User Facility

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE INNER SEAL HAS PULLED AWAY FROM THE CORNER ALLOWING MOISTURE INTO THE LIGHT PANELS CAUSING STREAKING AND DEBRIS INTERNALLY. BASED ON PHOTOGRAPHIC EVIDENCE PARTICLES MAY BE MISSING FROM THE SEAL. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK AND PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682444 ↗