Maquet Rolite ARDROL309031ARecalls & reported problems
Maquet Sas · ROL VCS40SF B · Class 2
All models of Maquet Rolite (17)
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 03700712417062), received between Sep 4, 2023 and Sep 4, 2023 — 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.
Recalls naming this device
- Nov 8, 2023Class IIOpen, Classified
A potential for a light system to fall in the operating room.
Z-0760-2024 · 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.
MalfunctionSep 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 23TH AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - ROLITE VOLISTA ACCESS. IT WAS STATED, AND CONFIRMED WITH PHOTOGRAPHIC EVIDENCE, THE IRON BETWEEN THE SUPPORT ARM OF THE MOBILE VOLISTA LAMP AND THE LIGHTHEAD IS IN A BROKEN CONDITION. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THIS BROKEN CONNECTION COULD LEAD TO DETACHMENT OF THE HEADLIGHT AND AS A RESULT OF THAT, COULD LEAD TO SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17676629 ↗
Other Light, Surgical, Floor Standing devices
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- LUCEA LED® ARDLCA309007AMaquet Sas · Light, surgical, floor standing1 recall1 report
- Maquet Rolite ARDROL309053AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309037AMaquet Sas · Light, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309041AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309043AMaquet Sas · Light, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309047AMaquet Sas · Light, surgical, floor standing1 recall0 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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