Maquet PowerLED II ARDPWT229061ARecalls & reported problems
Maquet Sas · PWDII70SF VP AIM CL K3 11 · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712411398), received between Jan 23, 2024 and Jul 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 Component2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 17TH JUNE, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THE UNIT HAD PHYSICAL DAMAGE WITH MISSING PARTICLES TO COVER DUE TO COLLISION. 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 19759036 ↗MalfunctionJan 23, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18562491 ↗
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 · 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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