LUCEA LED® ARDLCA219001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700712400651), received between May 7, 2022 and Dec 13, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Crack; 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 LED®. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE COVER WAS CRACKED RESULTING IN MISSING PARTICLES. 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 20923125 ↗
• MalfunctionOct 14, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 8TH OCTOBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THE COVERS OF THE DOMES WERE BROKEN DUE TO MISUSE AND THERE WAS A RISK OF THEM OR THEIR PARTS FALLING OFF. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE BROKEN IN SEVERAL PLACES AND SOME PARTS WERE MISSING. 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 20438040 ↗
• MalfunctionMay 29, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ON 23TH MAY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THE ACRYLIC FROM THE DOME FELL. IT WAS DISCOVERED BEFORE THE SURGERY AND FIXED WITH ADHESIVE TAPE. ACCORDING TO THE GETINGE TECHNICIAN, THE EQUPIMENT IS NOT RELEASED FOR USE. 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 19413545 ↗
• MalfunctionNov 2, 2023Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ LUCEA 100/100. AS IT WAS STATED AND CONFIRMED WITH THE PHOTOGRAPHIC EVIDENCE, THE HEADLIGHT COVERS ON BOTH DOMES WERE CRACKED WITH MISSING PARTICLES. THE ISSUE WAS DISCOVERED DURING DAILY CHECK UP. 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 18055426 ↗
• MalfunctionJun 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 17171713 ↗
• MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283003 ↗
• MalfunctionMay 7, 2022Overheating of Device; Overheating of Device

  ON 28TH OF APRIL, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 100 - SURGICAL LIGHT. AS IT WAS STATED, CONNECTION BETWEEN SPRING ARM AND FORK HAS OVERHEATED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS OVERHEATING MAY CAUSE FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315221 ↗