Home › VIVO SURGICAL PRIVATE LIMITED › KLARO In Vivo Surgical Lighting
KLARO In Vivo Surgical Lighting
VIVO SURGICAL PRIVATE LIMITED · Model 555-01-01 · UDI-DI 08881300212001
10
510(k) clearances
1,240
Adverse events (2 deaths)
49
Recalls
59
Facilities
Description
KLARO is a deep-cavity surgical LED lighting device for open surgery use. It is discreet, easy to use and provides bright, uniform and localised "flood-lighting" from within the surgical site. KLARO maintains a safe and cool working temperature suited for use inside the human body regardless of the luminous intensity selected.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.