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Vision1
BLACK DIAMOND VIDEO, INC. · Model VIS101 · UDI-DI 00724995209186
FGB
Prescription
3
510(k) clearances
6,977
Adverse events (7 deaths)
27
Recalls
119
Facilities
Description
The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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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.