POWERLED TM ARD568411710ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700712403003), received between Oct 17, 2023 and Oct 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  IN (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS CONFIGURATION ¿ POWERLED 700 AND POWERLED 300. AS IT WAS STATED, CORROSION HAS BUILT UP ON THE SPRING ARM. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955429 ↗
• MalfunctionOct 18, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 22ND SEPTEMBER, 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. AS IT WAS STATED, CORROSION HAS BUILT UP ON THE SPRING ARMS, BRAKE SCREWS AND COLLARS. PHOTOGRAPHIC INPUT CONFIRMED THAT ISSUE AND ALSO INDICATED THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON HEADLIGHT AND FORK. IT HAS COME TO CUSTOMER ATTENTION THAT THE CLEANING AGENT USED IN THEIR FACILITY WAS THE CAUSE OF THE MASSIVE CORROSION. 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 17955428 ↗
• MalfunctionOct 18, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 22ND SEPTEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. AS IT WAS STATED, CORROSION HAS BUILT UP ON THE SPRING ARM, FORKS, BRAKE SCREWS AND COLLARS. THEN, PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND ALSO INDICATED THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON HEADLIGHT AND FORK. IT HAS COME TO CUSTOMER ATTENTION THAT THE CLEANING AGENT USED IN THEIR FACILITY WAS THE CAUSE OF THE MASSIVE CORROSION. 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 17955425 ↗
• MalfunctionOct 17, 2023Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  ON 22ND SEPTEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. AS IT WAS STATED, CORROSION HAS BUILT UP ON THE SPRING ARMS, BRAKE SCREWS AND COLLARS. PHOTOGRAPHIC INPUT CONFIRMED THAT ISSUE AND ALSO INDICATED THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON HEADLIGHT AND FORK. IT HAS COME TO CUSTOMER ATTENTION THAT THE CLEANING AGENT USED IN THEIR FACILITY WAS THE CAUSE OF THE MASSIVE CORROSION. 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 17950785 ↗

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