POWERLED TM ARD568474114ARecalls & reported problems
Maquet Sas · PWD30+SF W K3 · Class 2
All models of POWERLED TM (280)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700712403478), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K070442); they may or may not involve this specific model.
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
- Aug 7, 2026Class IIOpen, Classified
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Z-3224-2026 · Root cause: Process control · Recall details · FDA record ↗
- Nov 8, 2023Class IIOpen, Classified
A potential for a light system to fall in the operating room.
Z-0763-2024 · 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.
MalfunctionJun 9, 2026Detachment of Device or Device Component
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED CLS. AS IT WAS STATED, CLIP ON THE SPRING ARM IS CROOKED, WITH THE RISK OF THE SPRING ARM DETACHMENT. 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 25443150 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070442. One submission often covers many models, so check the product and lot details in each record.
- Z-1990-2015 · May 29, 2015 · TerminatedThe PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling su
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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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