Maquet RoliteRecalls & reported problems across all models
Maquet Sas · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Maquet Rolite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 17 models of Maquet Rolite by Maquet Sas in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Maquet Rolite recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 8, 2023Open, Classified
A potential for a light system to fall in the operating room.
Z-0760-2024 · Root cause: Equipment maintenance · names 15 of these models · Recall details · FDA record ↗
- Nov 8, 2023Open, Classified
A potential for a light system to fall in the operating room.
Z-0757-2024 · Root cause: Equipment maintenance · names 2 of these models · Recall details · FDA record ↗
Most reported Maquet Rolite problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Maquet Rolite models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Maquet Rolite ARDROL309031ALight, Surgical, Floor Standing1 recall1 report
- Maquet Rolite ARDPWT309001ALight, Surgical, Floor Standing1 recall0 reports
- Maquet ROLITE ARDPWT309004ALamp, Surgical1 recall0 reports
- Maquet Rolite ARDPWT309006ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDPWT309007ALight, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDPWT309009ALight, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDPWT309015ALight, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309033ALight, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309037ALight, Surgical, Floor Standing1 recall0 reports
- Maquet Rolite ARDROL309039ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309041ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309043ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309045ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309047ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309049ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309051ALight, surgical, floor standing1 recall0 reports
- Maquet Rolite ARDROL309053ALight, surgical, floor standing1 recall0 reports
Recent Maquet Rolite adverse event reports
The 1 most recent reports across all models, 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 Maquet Sas products
- Maquet PowerLED II992 models · 138 reports · 1 recall
- POWERLED TM280 models · 79 reports · 2 recalls
- STANDOP VOLISTA23 models · 56 reports · 1 recall
- LUCEA LED33 models · 51 reports · 1 recall
- ROLITE VOLISTA STANDOP8 models · 0 reports · 2 recalls
- Maquet Equipment45 models · 8 reports · 1 recall
- Maquet Orchide5 models · 4 reports · 1 recall
- POWERLED2 models · 3 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page