POWERLED TM ARD568411110ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712402990), received between Aug 5, 2024 and Mar 20, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K070442); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Nov 8, 2023Open, Classified

   A potential for a light system to fall in the operating room.

   Z-0763-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗

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.

• MalfunctionMar 20, 2026Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT PAINT WAS PEELING OFF ON SPRING 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 24646870 ↗
• MalfunctionNov 12, 2024Corroded; Corroded

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661297 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. AS IT WAS STATED, THE STOPPER WAS ABSENT ON THE SPRING ARM. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS MISSING STOPPER COULD CAUSE DETACHMENT OF THE ARM INTO STERILE FIELD OR DURING PROCEDURE AND MAY CAUSE SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905014 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070442. One submission often covers many models, so check the product and lot details in each record.

• Z-3224-2026 · Aug 7, 2026 · Open, Classified
  PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
• Z-1990-2015 · May 29, 2015 · Terminated
  The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling su