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HexaVue
BLACK DIAMOND VIDEO, INC. · Model HexaVue-SLC 1.0 · UDI-DI 00724995198497
FTA
Prescription
10
510(k) clearances
391
Adverse events
6
Recalls
90
Facilities
Description
The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-23 | Steris Corporation | A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a docum |
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i |
| 2023-03-17 | Steris Corporation | Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i |
| 2017-10-13 | Ecolab, Inc. | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
| 2007-02-13 | Sunnex Inc. | Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder. |
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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.