Maquet PowerLED IIRecalls & reported problems across all models
Maquet Sas · 992 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Maquet PowerLED II model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 138
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 992 models of Maquet PowerLED II by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 138 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2022 and Jun 25, 2026 — classified as 1 injury, 137 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (81 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
Maquet PowerLED II 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-0757-2024 · Root cause: Equipment maintenance · names 957 of these models · Recall details · FDA record ↗
Most reported Maquet PowerLED II problems
Device problems
- Detachment of Device or Device Component81
- Peeled/Delaminated51
- Fluid/Blood Leak32
- Device Contaminated at the User Facility30
- Crack12
- Corroded3
- Leak/Splash2
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- Foreign Body In Patient1
- Skin Burning Sensation1
Maquet PowerLED II models
992 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Maquet PowerLED II ARDPWT259215ALamp, surgical1 recall30 reports
- Maquet PowerLED II ARDPWT209058ALamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT229064ALamp, Surgical1 recall3 reports
- Maquet PowerLED II ARDPWT259043ALamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT629089ALamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT209008ALamp, Surgical1 recall2 reports
- Maquet PowerLED II ARDPWT209033ALamp, Surgical1 recall2 reports
- Maquet PowerLED II ARDPWT259198ALamp, surgical1 recall2 reports
- Maquet PowerLED II ARDPWT229061ALamp, surgical1 recall2 reports
- Maquet PowerLED II ARDPWT609051ALamp, surgical1 recall2 reports
- Maquet PowerLED II ARDPWT209011ALamp, Surgical1 recall1 report
- Maquet PowerLED II ARDPWT209060ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT229063ALamp, Surgical1 recall1 report
- Maquet PowerLED II ARDPWT229090ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT239221ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT259283ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT609029ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT609033ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT609103ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT629035ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT629057ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT629063ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT629111ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT639073ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT659156ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT679062ALamp, surgical1 recall1 report
- Maquet PowerLED II ARDPWT209098ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209097ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209102ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209106ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209105ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209111ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209109ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209112ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209113ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209115ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209124ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209117ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209127ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209128ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209119ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209120ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209131ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209133ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209134ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209139ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209135ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209137ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209141ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229127ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209143ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229129ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229109ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229131ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229133ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229111ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229137ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229115ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229138ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229116ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229141ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229144ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229145ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229146ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229119ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229148ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229149ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229122ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229123ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT229124ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209001ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209003ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209007ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209010ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209012ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209014ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209015ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209019ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209020ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209025ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209027ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209037ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209038ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209039ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209041ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209042ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209045ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209046ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209049ALamp, Surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209051ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209055ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209056ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209059ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209062ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209063ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209067ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209068ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209073ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209075ALamp, surgical1 recall0 reports
- Maquet PowerLED II ARDPWT209081ALamp, surgical1 recall0 reports
Recent Maquet PowerLED II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Detachment of Device or Device Component
GETINGE BECOME AWARE OF AN ISSUE ISSUE WITH ONE OF SURGICAL LIGHTS - MAQUET POWERLED II. IT WAS STATED THAT THE PLASTIC COVER ON LIGHT ARM COMING LOOSE AND FELL OFF AT THE END OF OPERATION. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618673 ↗MalfunctionJun 25, 2026Detachment of Device or Device Component
GETINGE BECOME AWARE OF AN ISSUE ISSUE WITH ONE OF SURGICAL LIGHTS - MAQUET POWERLED II. IT WAS STATED THAT THE PLASTIC COVER ON LIGHT ARM COMING LOOSE AND FELL OFF AT THE END OF OPERATION. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618595 ↗MalfunctionMay 5, 2026Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT 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 25076739 ↗InjuryMar 26, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE INVOLVING ONE OF THE SURGICAL LIGHTS ¿ MAQUET POWERLED II. IT WAS REPORTED THAT THE BLACK PLASTIC COVER DETACHED FROM THE DOME ARM AND FELL INTO THE PATIENT'S ABDOMEN, WHERE IT CAME INTO CONTACT WITH THE AORTIC PROSTHESIS BEING IMPLANTED. THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTIC TREATMENT WITH CEFAZOLIN (2 G INTRAVENOUSLY AT H0, FOLLOWED BY 1 G INTRAVENOUSLY EVERY 4 HOURS) AND REMAINS UNDER CLINICAL AND BIOLOGICAL MONITORING AFTER THE SURGERY. WE DECIDED TO REPORT THIS ISSUE AS THE DESCRIBED OUTCOME IS CONSIDER TO MEET THE DEFINITION OF A SERIOUS INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 24699328 ↗MalfunctionFeb 11, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE INVOLVING ONE OF THE SURGICAL LIGHTS ¿ POWERLED II. IT WAS REPORTED THAT THE CONNECTION BETWEEN THE SUSPENSION ARM AND THE MAIN TUBE WAS FOUND TO BE LOOSE DUE TO THE LACK OF A CIRCLIP. NO INJURIES WERE REPORTED; HOWEVER, WE DECIDED TO REPORT THE ISSUE OUT OF AN ABUNDANCE OF CAUTION, AS A LOOSE SUSPENSION ARM MAY LEAD TO DETACHMENT OF THE DEVICE FROM THE CEILING AND COULD RESULT IN SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312470 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE COVER OF THE SPRING ARM OF THE SURGICAL LIGHTING DEVICE FELL OFF DURING SURGERY. UPON CHECKING THE COVER, THERE WERE IMPACT MARKS ON IT. IT APPEARS THAT PART OF THE COVER (THE TABS THAT FIT INTO PLACE) HAS BEEN DAMAGED DUE TO SOME KIND OF IMPACT. THE ISSUE DID NOT CAUSE ANY HEALTH ISSUES FOR THE PATIENT. 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 24035140 ↗MalfunctionJan 7, 2026Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988341 ↗MalfunctionDec 11, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23775748 ↗MalfunctionNov 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THERE WAS A GAP BETWEEN SPRING ARM AND SUSPENSION 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670220 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ POWERLED II. AS IT WAS STATED, THE COVER AT THE BASE OF THE SPRING ARM WAS SLIGHTLY DETACHED, CAUSING THE BRAKE TO BE LOOSE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE ISSUE CAN LEAD TO CONTAMINATION OF STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542607 ↗MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED II. IT WAS STATED THE COVER FELL OFF AND LANDED IN STERILE FIELD. 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 23497358 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
MANUFACTURER'S REFERENCE NUMBER OT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278190 ↗MalfunctionSep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE SPRING ARM COVER FELL. 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 23014517 ↗MalfunctionSep 9, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001573 ↗MalfunctionSep 9, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001117 ↗
Other Maquet Sas products
- POWERLED TM280 models · 79 reports · 2 recalls
- 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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