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STANDOP VOLISTA®
MAQUET SAS · Model ARDSAT209014A · UDI-DI 03700712405458
10
510(k) clearances
1,240
Adverse events (2 deaths)
49
Recalls
59
Facilities
Description
SAT VST40SF 13
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-04 | Baxter Healthcare Corporation | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products l |
| 2024-06-04 | Baxter Healthcare Corporation | Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products l |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2023-11-08 | Getinge Usa Sales Inc | A potential for a light system to fall in the operating room. |
| 2019-05-28 | Maquet Cardiovascular Us Sales, Llc | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may re |
| 2019-05-28 | Maquet Cardiovascular Us Sales, Llc | Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may re |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.