Maquet PowerLED II ARDPWT629089ARecalls & reported problems
Maquet Sas · PWDII75DF VP CL K4 SAX0810 · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700712425050), received between Apr 15, 2024 and Mar 19, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 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-0757-2024 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Detachment 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 21640474 ↗MalfunctionApr 15, 2024Peeled/Delaminated; Peeled/Delaminated
ON 2ND APRIL 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II. AS IT WAS STATED, THE PAINT WAS DAMAGED DURING ASSEMBLY DUE THE WAY THE DOME WAS PACKAGED IN THE SHIPPING BOX. IT WAS CONFIRMED THAT THE SURGICAL LIGHT WAS USED AFTER THE INSTALLATION WITH THIS ISSUE PRESENT ON THE DEVICE. THE DESIGNATED COMPLAINT UNIT EMPLOYEE ESTABLISHED BASED ON PHOTOGRAPHIC EVIDENCE THAT THE PAINT DAMAGE OCCURRED ON THE FORK. THERE WAS NO INJURY REPORTED, HOWEVER, 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 IN CASE OF REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19104452 ↗MalfunctionApr 15, 2024Peeled/Delaminated; Peeled/Delaminated
ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II. AS IT WAS STATED, THE PAINT WAS DAMAGED DURING ASSEMBLY AND THE DEVICE WAS USED AFTER THE INSTALLATION. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT THE ISSUE OCCURRED ON THE FORK. THERE WAS NO INJURY REPORTED, HOWEVER, 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 IN CASE OF REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19104242 ↗
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- Maquet PowerLED II ARDPWT229061AMaquet Sas · Lamp, surgical1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.