POWERLED TMRecalls & reported problems across all models
Maquet Sas · 280 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one POWERLED TM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 280 models of POWERLED TM by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 79 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2022 and Jun 9, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (41 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
POWERLED TM 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.
- Aug 7, 2026Open, Classified
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Z-3224-2026 · Root cause: Process control · Recall details · FDA record ↗
- Nov 8, 2023Open, Classified
A potential for a light system to fall in the operating room.
Z-0763-2024 · Root cause: Equipment maintenance · names 279 of these models · Recall details · FDA record ↗
Most reported POWERLED TM problems
Device problems
- Peeled/Delaminated41
- Detachment of Device or Device Component31
- Material Erosion12
- Corroded10
- Crack7
- Material Split, Cut or Torn5
- Break1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions79
POWERLED TM models
280 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- POWERLED TM ARD568474114ALight, surgical, ceiling mounted2 recalls1 report
- POWERLED TM ARDPWD259001ALight, surgical, ceiling mounted1 recall14 reports
- POWERLED TM ARD568425010ALight, surgical, ceiling mounted1 recall11 reports
- POWERLED TM ARD568415010ALight, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568446710ALight, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568410010ALight, surgical, ceiling mounted1 recall5 reports
- POWERLED TM ARD568411710ALight, surgical, ceiling mounted1 recall4 reports
- POWERLED TM ARD568411110ALight, surgical, ceiling mounted1 recall3 reports
- POWERLED TM ARD568420710ALight, surgical, ceiling mounted1 recall3 reports
- POWERLED TM ARD568446512ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568420051ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568420752ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568446010ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568420010ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARDPWD209038ALight, surgical, ceiling mounted1 recall2 reports
- POWERLED TM ARD568446751ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568420512ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568415710ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568436010ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARDPWD229013ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARDPWD229016ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568410710ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568421710ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568431010ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARDPWD209032ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARDPWD209012ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD568421210ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD268400150ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD268400140ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARD268300170ALight, surgical, ceiling mounted1 recall1 report
- POWERLED TM ARDROL309008ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDROL309009ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDROL309010ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDROL309011ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425051ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425052ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425511ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425512ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568425752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568446051ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568446052ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568446511ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568446513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568446752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259004ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259006ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259007ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259008ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259009ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259010ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259011ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259012ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259013ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259014ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259015ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD259016ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568411751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568411752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568420052ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568420511ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568420513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568420751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421051ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421052ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421511ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421512ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568421752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568424511ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568424512ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568424513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568431751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568431752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568441051ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568441052ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568441513ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568441751ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568441752ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239000ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239002ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239003ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239004ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239005ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239006ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239007ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239008ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239009ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239010ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239011ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239012ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239013ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239014ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239015ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239016ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239017ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARDPWD239018ALight, surgical, ceiling mounted1 recall0 reports
- POWERLED TM ARD568415110ALight, surgical, ceiling mounted1 recall0 reports
Recent POWERLED TM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED CLS. AS IT WAS STATED, CLIP ON THE SPRING ARM IS CROOKED, WITH THE RISK OF THE SPRING ARM DETACHMENT. 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 25443150 ↗MalfunctionMar 20, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT PAINT WAS PEELING 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 24646870 ↗MalfunctionFeb 5, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE PAINT WAS CHIPPING ON FORK. 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 24267513 ↗MalfunctionJan 28, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT WAS CHIPPING ON FORK. 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 24198047 ↗MalfunctionJan 15, 2026Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24078003 ↗MalfunctionJan 12, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE PAINT WAS CHIPPING FROM FORK DUE TO IMPACT. 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 24035351 ↗MalfunctionJan 12, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE PAINT WAS CHIPPING FROM FORK DUE TO IMPACT. 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 24035220 ↗MalfunctionJan 8, 2026Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24002151 ↗MalfunctionJan 7, 2026Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988320 ↗MalfunctionDec 30, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23920055 ↗MalfunctionNov 13, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542920 ↗MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING OFF ON FORK, HEADLIGHT AND HANDLE. 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 23378184 ↗MalfunctionOct 24, 2025Peeled/Delaminated; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE PAINT WAS CHIPPING OFF ON FORK. 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 23378105 ↗MalfunctionOct 17, 2025Break; Peeled/Delaminated; Detachment of Device or Device Component; Break; Peeled/Delaminated; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, UPON THE DEVICE INSPECTION ONE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS BROKEN 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 23321089 ↗MalfunctionOct 15, 2025Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED THE PAINT WAS CHIPPING FROM WHITE DOME COVER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO INDICATION OF MISSING PARTICLES AS THE MENTIONED PART IS NOT PAINTED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288569 ↗
Other Maquet Sas products
- Maquet PowerLED II992 models · 138 reports · 1 recall
- STANDOP VOLISTA23 models · 56 reports · 1 recall
- Maquet Rolite17 models · 1 reports · 2 recalls
- LUCEA LED33 models · 51 reports · 1 recall
- 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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