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LUCEA LED® ARDLCA309007ARecalls & reported problems

Maquet Sas · LCA 100 MOBILE B · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712400729), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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

Device problems

  • Crack1
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMar 29, 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 SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THE HEADLIGHT STRUCTURE WAS DAMAGED. BASED ON PHOTOGRAPHIC EVIDENCE THE COVER WAS CRACKED WITH MISSING PARTICLES. 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 16635304 ↗

Other Light, surgical, floor standing devices

All Light, surgical, floor standing devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.