Maquet PowerLED II ARDPWT679062ARecalls & reported problems
Maquet Sas · PWDII70DF VP4K CL K3 SAX08 · Class 2
All models of Maquet PowerLED II (992)
Data updated Oct 18, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712431372), received between Feb 11, 2026 and Feb 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 18, 2026.
Reports received per month
Recalls naming this device
- Nov 8, 2023Class IIOpen, Classified
A potential for a light system to fall in the operating room.
Z-0757-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
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 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 ↗
Other Lamp, surgical devices
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- 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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