Maquet PowerLED II ARDPWT609009ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712422929), received between May 8, 2024 and Jun 25, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 25, 2026Detachment of Device or Device Component

  GETINGE BECOME AWARE OF AN ISSUE ISSUE WITH ONE OF SURGICAL LIGHTS - MAQUET POWERLED II. IT WAS STATED THAT THE PLASTIC COVER ON LIGHT ARM COMING LOOSE AND FELL OFF AT THE END OF OPERATION. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618673 ↗
• InjuryMar 26, 2026Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE INVOLVING ONE OF THE SURGICAL LIGHTS ¿ MAQUET POWERLED II. IT WAS REPORTED THAT THE BLACK PLASTIC COVER DETACHED FROM THE DOME ARM AND FELL INTO THE PATIENT'S ABDOMEN, WHERE IT CAME INTO CONTACT WITH THE AORTIC PROSTHESIS BEING IMPLANTED. THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTIC TREATMENT WITH CEFAZOLIN (2 G INTRAVENOUSLY AT H0, FOLLOWED BY 1 G INTRAVENOUSLY EVERY 4 HOURS) AND REMAINS UNDER CLINICAL AND BIOLOGICAL MONITORING AFTER THE SURGERY. WE DECIDED TO REPORT THIS ISSUE AS THE DESCRIBED OUTCOME IS CONSIDER TO MEET THE DEFINITION OF A SERIOUS INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24699328 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2ND MAY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE DUST COVER FROM SPRING ARM FELL ON THE FLOOR, WHEN SURGEON ADJUSTED LIGHT POSITION. 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 CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267026 ↗