LUCEA LED® ARDLCA309005ARecalls & reported problems
Maquet Sas · LCA 50 MOBILE B · Class 2
All models of LUCEA LED (33)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712400743), received between Apr 30, 2024 and Jul 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- Nov 8, 2023Open, Classified
A potential for a light system to fall in the operating room.
Z-0759-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 19TH JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE SPRING ARM'S CAP WAS MISSING. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19824961 ↗MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 24TH APRIL, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE PROTECTIVE COVER FROM THE SPRING ARM AND SCREW THAT LOCKED CENTRAL PEDESTAL TO THE BASE WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19211109 ↗
Other Light, surgical, floor standing devices
- HarmonyAIR A-Series Mobile LightSteris Corporation · Light, surgical, floor standing2 recalls0 reports
- Maquet Rolite ARDROL309031AMaquet Sas · Light, Surgical, Floor Standing1 recall1 report
- LUCEA LED® ARDLCA309007AMaquet Sas · Light, surgical, floor standing1 recall1 report
- Maquet Rolite ARDROL309047AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309033AMaquet Sas · Light, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309051AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- iLED7 Surgical Light 4068120Baxter Medical Systems GmbH + Co. KG · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDPWT309007AMaquet Sas · Light, Surgical, Floor Standing1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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