ROLITE VOLISTA STANDOPRecalls & reported problems across all models
Maquet Sas · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ROLITE VOLISTA STANDOP 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
- 2
We found 8 models of ROLITE VOLISTA STANDOP by Maquet Sas in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
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
ROLITE VOLISTA STANDOP 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 8 of these models · Recall details · FDA record ↗
- May 6, 2022Open, Classified
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
Z-1308-2022 · Root cause: Process change control · names 3 of these models · Recall details · FDA record ↗
ROLITE VOLISTA STANDOP models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROLITE VOLISTA STANDOP ARDROL309022ALight, surgical, ceiling mounted2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309018ALamp, surgical2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309023ALamp, surgical2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309016ALamp, surgical1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309017ALamp, surgical1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309020ALight, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309019ALamp, surgical1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309021ALight, 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
- 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.
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