LUCEA LEDRecalls & reported problems across all models
Maquet Sas · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LUCEA LED model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 33 models of LUCEA LED by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between May 7, 2022 and Apr 9, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
LUCEA LED recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 8, 2023Open, Classified
A potential for a light system to fall in the operating room.
Z-0759-2024 · Root cause: Equipment maintenance · names 28 of these models · Recall details · FDA record ↗
Most reported LUCEA LED problems
Device problems
- Detachment of Device or Device Component39
- Peeled/Delaminated14
- Crack10
- Grounding Malfunction1
- Installation-Related Problem1
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
LUCEA LED models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LUCEA LED® ARDLCA209012ALight, Surgical, Ceiling Mounted1 recall20 reports
- LUCEA LED® ARDLCA219001ALight, Surgical, Ceiling Mounted1 recall7 reports
- LUCEA LED® ARDLCA219003ALight, Surgical, Ceiling Mounted1 recall5 reports
- LUCEA LED® ARDLCA219000ALight, Surgical, Ceiling Mounted1 recall3 reports
- LUCEA LED® ARDLCA219002ALight, Surgical, Ceiling Mounted1 recall2 reports
- LUCEA LED® ARDLCA309005ALight, surgical, floor standing1 recall2 reports
- LUCEA LED® ARDLCA219005ALight, Surgical, Ceiling Mounted1 recall1 report
- LUCEA LED® ARDLCA219004ALight, Surgical, Ceiling Mounted1 recall1 report
- LUCEA LED® ARDLCA309007ALight, surgical, floor standing1 recall1 report
- LUCEA LED® ARDLCA109005ALamp, surgical1 recall1 report
- LUCEA LED® ARDLCA209015ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDLCA209013ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDLCA209016ALed light source1 recall0 reports
- LUCEA LED® ARDLCA109008ALed light source1 recall0 reports
- LUCEA LED® ARDLCA109004ALamp, surgical1 recall0 reports
- LUCEA LED® ARDLCA109007ALamp, surgical1 recall0 reports
- LUCEA LED® ARDSAT209005ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDSAT209009ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDSAT209002ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDSAT209006ALight, Surgical, Ceiling Mounted1 recall0 reports
- LUCEA LED® ARDLCA506000ALed light source1 recall0 reports
- LUCEA LED® ARDLCA506003ALamp, surgical1 recall0 reports
- LUCEA LED® ARDLCA506005ALamp, surgical1 recall0 reports
- LUCEA LED® ARDLCA506006ALed light source1 recall0 reports
- LUCEA LED® ARDLCA109006ADevice, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA209021ADevice, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA309008ADevice, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA309009ADevice, Medical Examination, Ac Powered1 recall0 reports
- LUCEA LED® ARDLCA309004ALight, surgical, floor standing4 reports
- LUCEA LED® ARDLCA309006ALight, surgical, floor standing1 report
- LUCEA LED® ARDLCA109001ADevice, Medical Examination, Ac Powered1 report
- LUCEA LED® ARDLCA209012ADevice, medical examination, ac powered1 report
- LUCEA LED® ARDLCA309004ADevice, medical examination, ac powered1 report
Recent LUCEA LED adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT WAS CHIPPING OFF ON SPRING ARM. 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 24826351 ↗MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT THE PAINT WAS CHIPPING FROM THE SPRING ARM. 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 23378044 ↗MalfunctionJul 14, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22492160 ↗MalfunctionFeb 25, 2025Crack; 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 21457031 ↗MalfunctionFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED THE CAP DETACHED FROM THE SPRING ARM. 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 21363789 ↗MalfunctionFeb 6, 2025Crack; Crack
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS FOUND DURING PERIODIC INSPECTION AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE UPPER HEAD LIGHT COVERS WERE DAMAGE WITH MISSING PARTICLES. THE ISSUE OCCURRED DUE TO COLLISION OF LAMPS. 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 IN CASE OF REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21320788 ↗MalfunctionJan 22, 2025Crack; 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 100. IT WAS STATED THE HEADLIGHT COVER NEED TO BE REPLACED, AS SOME PARTS COME LOSE, PROBABLY DUE TO COLLISION WITH ANOTHER DEVICE. 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 21205456 ↗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 ↗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 ↗MalfunctionDec 3, 2024Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20829383 ↗MalfunctionDec 3, 2024Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20829382 ↗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 ↗MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469712 ↗MalfunctionOct 17, 2024Peeled/Delaminated; Peeled/Delaminated
ON 8TH OCTOBER, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE PAINT WAS PEELING FROM FORK. THE ISSUE WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. 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 20469076 ↗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 ↗
Other Maquet Sas products
- Maquet PowerLED II992 models · 138 reports · 1 recall
- POWERLED TM280 models · 79 reports · 2 recalls
- STANDOP VOLISTA23 models · 56 reports · 1 recall
- Maquet Rolite17 models · 1 reports · 2 recalls
- ROLITE VOLISTA STANDOP8 models · 0 reports · 2 recalls
- Maquet Equipment45 models · 8 reports · 1 recall
- Maquet Orchide5 models · 4 reports · 1 recall
- POWERLED2 models · 3 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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