Maquet PowerLED II ARDPWT209142ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712406615), received between Dec 29, 2022 and Oct 30, 2024 — classified as 3 malfunctions.

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

• MalfunctionOct 30, 2024Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT AND LABEL WERE CHIPPING FROM THE SUSPENSION ARM. 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 20566700 ↗
• MalfunctionMar 11, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 29TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 500. AS IT WAS STATED, PAINT DAMAGE OCCURRED ON THE SUSPENSION ARM, THE PROBLEM WAS DISCOVERED DURING MAINTENANCE. IT WAS CONFIRMED BY TECHNICIAN THE MECHANICAL DAMAGE OCCURRED DUE TO COLLISION. DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT ALSO THE LABEL WAS CHIPPING FROM SUSPENSION ARM. 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 OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873171 ↗
• MalfunctionDec 29, 2022Peeled/Delaminated; Unstable; Detachment of Device or Device Component; Peeled/Delaminated; Unstable; Detachment of Device or Device Component

  ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED SCREW CONNECTION OF THE CENTRAL AXIS IN THE CEILING TUBE IS DEFECTIVE. ALL INTERNAL THREADS IN THE CENTRAL AXLE ARE DAMAGED AND NONE OF THE 6 SCREWS HOLD POSITION CAUSING UNEVEN CONNECTION. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THIS UNSTABLE CONNECTION 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 16066536 ↗