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BLACK DIAMOND VIDEO, INC. · Model IDSS-SLC Version 8 · UDI-DI 00724995163723

FTA Prescription

510(k) clearances

373

Adverse events

Recalls

Facilities

Description

The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.

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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Data 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.