Maquet PowerLED II ARDPWT229114ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712406790), received between Mar 5, 2024 and Oct 31, 2024 — 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.

• MalfunctionOct 31, 2024Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 700. IT WAS STATED THE LIGHT ARMS WERE SCRATCHED AND SOME PARTICLES WERE MISSING. PHOTOGRAPHIC EVIDENCE INDICATED THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON ARMS AND RUST WAS PRESENT ON 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. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS THE SAME AS ALREADY REPORTED UNDER MANUFACTURER¿S REFERENCE NUMBER: (B)(4) (REPORT NUMBER: 9710055-2024-00193). FOLLOWING THE DETECTION OF THE ISSUE IN (B)(6) 2024, THE QUOTATION WAS NOT ACCEPTED BY THE CUSTOMER AND THE ISSUE HAS NOT BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576437 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 29TH FEBRUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II 700. 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. 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 IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836258 ↗