Maquet PowerLED II ARDPWT259054ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712408749), received between Jun 26, 2024 and Jul 31, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionJul 31, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 11TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE HEADLIGHT COVER FASTENERS WERE BROKEN IN SEVERAL LOCATIONS AROUND THE COVER. PARTS OF BROKEN CLIP HAD FALLEN INTO THE SURROUNDING GASKET AND INTO THE LIGHTHEAD. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES IN SEVERAL LOCATIONS. 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 19871948 ↗
• MalfunctionJul 12, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 29TH MAY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ POWERLED II. IT WAS DETERMINED THE ISSUE DESCRIBED WITHIN COMPLAINT IS NOT SAFETY AND RISK RELATED. ON 4TH JUNE 2024 FURTHER INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN FOLLOWING THE VISIT AT THE CUSTOMER SITE AND DEVICE EVALUATION THAT LIGHT HEAD COPULA/LENS WAS FOUND FALLING APART. THE COPULA IS CRACKED COMPLETELY ON A TAP SIDE WITH ALSO MISSING THE TAP. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19728256 ↗
• MalfunctionJun 26, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 22ND JUNE 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE DUAL FORK ASSEMBLY OF THE LIGHTHEAD HAS BEEN DAMAGED. IT WAS CONFIRMED BY VIDEO EVIDENCE THE CONNECTION BETWEEN FORK AND SPRING ARM WAS DAMAGED WITH RISK OF DETACHMENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK OF THE LIGHT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BREAK ON THE CONNECTION BETWEEN FORK AND SPRING ARM 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 19612919 ↗