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VS3 Iridium
VISIONSENSE LTD. · Model 465-0011RFB · UDI-DI 10884521844698
OWN
Prescription
1
510(k) clearances
1,559
Adverse events (1 deaths)
4
Recalls
69
Facilities
Description
VS3 Iridium - Laser Light Source, 785nm (LLS)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-24 | Olympus Corporation of the Americas | Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the devic |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
| 2022-10-17 | Visionsense, Ltd. | XXX |
| 2022-10-17 | Visionsense, Ltd. | Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. |
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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.