Home › BLACK DIAMOND VIDEO, INC. › NA

NA

BLACK DIAMOND VIDEO, INC. · Model IDSS-SLC · UDI-DI 00724995153083

FTA Prescription

510(k) clearances

373

Adverse events

Recalls

Facilities

Description

The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.

Recalls

Date	Firm	Reason
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.

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 key Read the docs

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.