POWERLED TM ARD568420710ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712403089), received between May 8, 2023 and Aug 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19970219 ↗
• MalfunctionJul 31, 2024Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 18TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED THE PAINT WAS CHIPPING FROM DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19872491 ↗
• MalfunctionMay 8, 2023Corroded; Peeled/Delaminated; Detachment of Device or Device Component; Corroded; Peeled/Delaminated; Detachment of Device or Device Component

  ON 4TH MAY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED 500/300. AS IT WAS STATED, THE CORROSION HAS BUILT UP ON THE DEVICE. ADDITIONALLY, ACCORDING TO PHOTOGRAPHIC EVIDENCE, PAINT WAS PEELING FROM THE FORK AND LABEL WAS DAMAGED WITH MISSING PARTICLES. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886458 ↗

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