LUCEA LED® ARDLCA309006ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712400712), received between Dec 27, 2024 and Dec 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Unintended Electrical Shock; Unintended Electrical Shock

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100 MOBILE. IT WAS STATED THE POWER PLUG IS COMING OUT - ONE OF THE LEFT AND RIGHT PRONGS OF THE POWER PLUG WAS BROKEN. THE ISSUE WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF PLUG WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK IN CASE OF REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026100 ↗

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