LUCEA LED® ARDLCA219003ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700712400620), received between Mar 11, 2024 and Feb 25, 2025 — classified as 5 malfunctions.

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

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

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-0759-2024 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Crack; 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 21457031 ↗
• MalfunctionJan 22, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THE HEADLIGHT COVER NEED TO BE REPLACED, AS SOME PARTS COME LOSE, PROBABLY DUE TO COLLISION WITH ANOTHER DEVICE. 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 OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21205456 ↗
• MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469712 ↗
• MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated

  ON 8TH OCTOBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE PAINT WAS PEELING FROM FORK. THE ISSUE WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. 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 20469076 ↗
• MalfunctionMar 11, 2024Grounding Malfunction; Grounding Malfunction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874560 ↗