Maquet PowerLED II ARDPWT209009ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712407216), received between Aug 16, 2023 and Jul 10, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Peeled/Delaminated; Peeled/Delaminated

  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 HEADLIGHT. 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 22468729 ↗
• MalfunctionAug 16, 2023Peeled/Delaminated; Peeled/Delaminated

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II 700. AS IT WAS STATED, UPON THE PREVENTIVE MAINTENANCE ACTIVITIES BEING PERFORMED ON THE DEVICE, THE PAINT DAMAGE WAS IDENTIFIED. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, PAINT WAS CHIPPING OFF FROM FORK AND KEYPAD MEMBRANE WAS DAMAGED 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 17554784 ↗