LUCEA LED® ARDLCA309004A (UDI 03700712400736)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700712400736), received between Mar 17, 2023 and Nov 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K113679); 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.

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.

• MalfunctionNov 14, 2024Crack; Peeled/Delaminated; Detachment of Device or Device Component; Crack; Peeled/Delaminated; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681700 ↗
• MalfunctionNov 23, 2023Detachment 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 18197993 ↗
• MalfunctionSep 19, 2023Crack; Peeled/Delaminated; Detachment of Device or Device Component; Crack; Peeled/Delaminated; Detachment of Device or Device Component

  ON (B)(6), 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES, THE HEADLIGHT WAS HANGING ON CABLES AND THE PAINT WAS CHIPPING FROM THE ARM. 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 17771401 ↗
• MalfunctionMar 17, 2023Peeled/Delaminated; Peeled/Delaminated

  ON 17TH FEBRUARY 2023 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SURGICAL LIGHTS - LUCEA 50. ON 13TH MARCH 2023, SERVICE TECHNICIAN ARRIVED ON SITE AND DETECTED REPORTABLE ISSUE. ACCORDING TO PHOTOGRAPHIC EVIDENCE, THE PAINT WAS DAMAGED ON THE SPRING ARM AND PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, 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 16563319 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113679. One submission often covers many models, so check the product and lot details in each record.

• Z-0759-2024 · Nov 8, 2023 · Open, Classified
  Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA10