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Maquet PowerLED II
MAQUET SAS · Model ARDPWT259153A · UDI-DI 03700712409708
10
510(k) clearances
1,238
Adverse events (2 deaths)
49
Recalls
59
Facilities
Description
PWDII50DF VP AIM MHS021 K3 1011
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.