ROLITE VOLISTA ACCESSRecalls & reported problems across all models
Maquet Sas · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one ROLITE VOLISTA ACCESS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of ROLITE VOLISTA ACCESS by Maquet Sas in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device 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. 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
ROLITE VOLISTA ACCESS 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-0758-2024 · Root cause: Equipment maintenance · names 4 of these models · Recall details · FDA record ↗
ROLITE VOLISTA ACCESS models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROLITE VOLISTA ACCESS ARDROL309024ALight, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309028ALight, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309025ALamp, surgical1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309029ALight, surgical, ceiling mounted1 recall0 reports
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
- Maquet Rolite17 models · 1 reports · 2 recalls
- 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
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.
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