POWERLED TM ARD568425010ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03700712402563), received between Sep 20, 2023 and Oct 24, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING OFF ON FORK, HEADLIGHT AND HANDLE. 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 23378184 ↗
• MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING OFF ON FORK. 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 23378105 ↗
• MalfunctionOct 17, 2025Break; Peeled/Delaminated; Detachment of Device or Device Component; Break; Peeled/Delaminated; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321089 ↗
• MalfunctionAug 14, 2024Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981324 ↗
• MalfunctionAug 14, 2024Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  ON 08TH AUGUST, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED TM. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE PAINT WAS CHIPPING FROM HEADLIGHT'S HANDLE, FORK AND THE LABEL WAS ALSO CHIPPING OFF. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT AND LABEL PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981322 ↗
• MalfunctionAug 6, 2024Peeled/Delaminated; Detachment of Device or Device Component; Material Split, Cut or Torn; Peeled/Delaminated; Detachment of Device or Device Component; Material Split, Cut or Torn

  ON 31ST JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. DURING PREVENTIVE MAINTENANCE BY GETINGE, THE PAINT DAMAGE (CHIPPED PAINT) WAS FOUND ON THE ENTIRE LIGHTING SYSTEM. IN ADDITION, THE FASTENING SCREWS FOR THE COVERS WERE MISSING ON A SPRING ARM. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FORM HEADLIGHT HANDLE, SUSPENSION ARM AND SPRING ARM AND FORK, THE LABELS WERE TORN WITH MISSING PARTICLES AND THE SCREWS AND CAPS WERE MISSING FROM SPRING ARM. 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 19916161 ↗
• MalfunctionJul 16, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 8TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. DURING PREVENTIVE MAINTENANCE PAINT DAMAGE WAS DISCOVERED ON THE ENTIRE LIGHTING SYSTEM. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING FROM THE HEADLIGHT, FORK, ARMS AND HEADLIGHT HANDLE. 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 19749460 ↗
• MalfunctionJul 12, 2024Peeled/Delaminated; Detachment of Device or Device Component; Scratched Material; Material Split, Cut or Torn; Peeled/Delaminated; Detachment of Device or Device Component; Scratched Material; Material Split, Cut or Torn

  ON 8TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. DURING PREVENTIVE MAINTENANCE IT WAS FOUND THAT PAINT WAS DAMAGED WITH MISSING PARTICLES ON SUSPENSION ARM, SPRING ARM, FORK AND HEADLIGHT HANDLE AND COVERS OF THE SPRING ARMS WERE DAMAGED. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUES AND ALSO INDICATED THAT LABEL ON SUSPENSION ARM WAS DAMAGED WITH MISSING PARTICLES AND DUST COVER WAS MISSING FROM SPRING ARM. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729365 ↗
• MalfunctionSep 22, 2023Crack; Peeled/Delaminated; Detachment of Device or Device Component; Crack; Peeled/Delaminated; Detachment of Device or Device Component

  ON 4TH SEPTEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA DUO 100. INITIALLY, THERE WAS NOT ENOUGH INFORMATION TO DETERMINE WHETHER THE ISSUE WAS SAFETY AND RISK RELATED. AFTER THE VISIT OF TECHNICIAN IN THE FACILITY THAT TOOK PLACE ON (B)(6) 2023, WE RECEIVED PHOTOS AND MORE INFORMATION ABOUT THE AFFECTED DEVICE. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE AND PHOTOGRAPHIC EVIDENCE THE COVERS OF DOMES WERE CRACKED WITH MISSING PARTICLES AND THE PAINT WAS CHIPPING FROM FORK AND SPRING ARM. IT WAS STATED BY TECHNICIAN THAT NO COLLISION POINTS WERE FOUND TO PROVE IMPROPER USE AND THE SEVERAL DAMAGES ARE POSSIBLY DILATATION OF THE MATERIAL. 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 17797226 ↗
• MalfunctionSep 21, 2023Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787581 ↗
• MalfunctionSep 20, 2023Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 500. IT WAS STATED THE DUST COVERS HAD CAME OFF THE SPRING ARM. IT HAS BEEN BROUGHT TO GETINGE TECHNICIAN ATTENTION THAT NIGHT SHIFT HOSPITAL ENGINEERS HAVE BEEN PUTTING THEM BACK IN THEMSELVES PRIOR TO THE INCIDENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17779105 ↗

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