Maquet PowerLED II ARDPWT609163ARecalls & reported problems
Maquet Sas · PWDII75DF K3 XO SAX081012 · Class 2
All models of Maquet PowerLED II (992)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712434281), received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Power Problem” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Power Problem1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2025Power Problem; Unintended Electrical Shock; Power Problem; Unintended Electrical Shock
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS ¿ POWERLED II. IT WAS DETERMINED THAT THE ISSUE FROM THE COMPLAINT IS NOT SAFETY AND RISK RELATED. THEN, ON 22TH JANUARY 2024, FURTHER INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN FOLLOWING THE VISIT AT THE CUSTOMER SITE AND DEVICE EVALUATION. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT THE WPS POWER SUPPLY CABLES WERE LOOSE ON AN ELECTRICAL CONTROL CABINET, OPEN AT THE TOP, WITHOUT A COVER, RESULTING A RISK OF ELECTRIC SHOCK. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL OF ELECTRICAL SHOCK FOR OPERATOR OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21408675 ↗
Other Lamp, surgical devices
- ROLITE VOLISTA STANDOP ARDROL309023AMaquet Sas · Lamp, surgical2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309018AMaquet Sas · Lamp, surgical2 recalls0 reports
- Maquet PowerLED II ARDPWT259215AMaquet Sas · Lamp, surgical1 recall30 reports
- iLED7 Surgical Light 4068310Baxter Medical Systems GmbH + Co. KG · Lamp, surgical1 recall5 reports
- Maquet PowerLED II ARDPWT629089AMaquet Sas · Lamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT259043AMaquet Sas · Lamp, surgical1 recall3 reports
- Maquet PowerLED II ARDPWT229064AMaquet Sas · Lamp, Surgical1 recall3 reports
- Maquet PowerLED II ARDPWT209058AMaquet Sas · Lamp, surgical1 recall3 reports
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page