POWERLED TM ARD568431010ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712403171), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 30TH SEPTEMBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE DOME DETACHED FROM THE LIGHT. THE SCREW THAT SECURE THE DOME WITH ARCH HAS COME LOOSE AND ONE OF THE SCREWS WAS BROKEN IN THE THREAD. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DETACHMENT OF HEADLIGHT DURING PROCEDURE COULD LEAD TO SERIOUS INJURY AND FALLING OF SCREW OR IT PARTICLES INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365996 ↗

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