POWERLED ARD267800200ARecalls & reported problems
Maquet Sas · PWD33S SHELTER · Class 2
All models of POWERLED (2)
Data updated Oct 16, 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
- 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 03700712406103), received between Oct 20, 2023 and Nov 3, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Corroded” (3 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 16, 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-0763-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Corroded3
- Detachment of Device or Device Component3
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.
MalfunctionNov 3, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
ON 5TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND ALSO CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT SPRING ARM COVER SCREWS AND CEILING MOUNTING HARDWARE WERE RUSTED AND THAT COVER ON CEILING MOUNT WAS MISSING. DEVICE WAS INSTALLED ON THE SHIP WHICH IS STILL UNDER CONSTRUCTION. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064524 ↗MalfunctionNov 3, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
ON 5TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT RUST OCCURRED ON CEILING MOUNTING BOLTS/STUDS AND NUTS, AND ALSO THERE WAS LACK OF CEILING COVER WHICH COULD LEAD TO FALLING CONTAMINATIONS FROM THE HOLE ABOVE CEILING TO STERILE FIELD. DEVICE WAS INSTALLED BY ONSITE CUSTOMER CONTRACTORS ON THE SHIP, WHICH IS STILL UNDER CONSTRUCTION, THE DEVICE IS NOT IN SERVICE BY CUSTOMER YET. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES OR OTHER PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18064428 ↗MalfunctionOct 20, 2023Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component
ON 5TH OCTOBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THAT RUST OCCURRED ON CEILING MOUNTING BOLTS/STUDS AND NUTS, AND ALSO THERE WAS LACK OF CEILING COVER WHICH COULD LEAD TO FALLING CONTAMINATIONS FROM THE HOLE ABOVE CEILING TO STERILE FIELD. DEVICE WAS INSTALLED BY ONSITE CUSTOMER CONTRACTORS ON THE SHIP, WHICH IS STILL UNDER CONSTRUCTION, THE DEVICE IS NOT IN SERVICE BY CUSTOMER YET. NO CLEANING OR DISINFECTION PROCESSES HAVE BEEN PERFORMED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLES OR OTHER PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17975631 ↗
Other Light, surgical, ceiling mounted devices
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- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- POWERLED TM ARD568474114AMaquet Sas · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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