LUCEA LED® ARDLCA209012A (UDI 03700712400637)Recalls & reported problems
Maquet Sas · LCA 50 · 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
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03700712400637), received between Jan 31, 2023 and Dec 3, 2024 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 Component18
- Peeled/Delaminated2
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 27, 2024Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component
MANUFACTURER'S REFERENCE NUMBER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20320131 ↗MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 1ST AUGUST, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA LED®. IT WAS STATED THE COVER'S SCREW 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 19981430 ↗MalfunctionJul 9, 2024Detachment 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 19698906 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED THE COVER DETACHED FROM THE DEVICE. 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 IN CASE OF REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19678132 ↗MalfunctionJul 1, 2024Detachment 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 19641451 ↗MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 3RD APRIL, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, THE CAP WAS MISSING ON THE SPRING ARM. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE 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 IN CASE OF REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19085936 ↗MalfunctionApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 3RD APRIL, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. DURING ANNUAL PREVENTIVE MAINTENANCE IT WAS FOUND THAT CAP WAS MISSING FROM THE SPRING ARM. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE. 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 19049023 ↗MalfunctionMar 28, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
ON 26TH MARCH, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP ON THE SPRING ARM WAS 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 18996306 ↗MalfunctionNov 7, 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 18083713 ↗MalfunctionJul 27, 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 17403179 ↗MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 24TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE CAP WAS MISSING FROM THE SPRING ARM. 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 17395853 ↗MalfunctionJul 21, 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 17368885 ↗MalfunctionMar 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6)2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ LUCEA 50. AS IT WAS STATED, SPRING ARM'S COVER 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 16553241 ↗MalfunctionMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16494689 ↗MalfunctionMar 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 20TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16493882 ↗MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16491731 ↗MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 20TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WAS LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16484380 ↗MalfunctionJan 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. IT WAS STATED THE BRAKE COVER WAS MISSING FROM THE DEVICE. 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 16270786 ↗
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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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