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View Medical SurgiLight

BihlerMed, L.L.C. · Model 2816-01-0001 · UDI-DI 10865082000181

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510(k) clearances

373

Adverse events

Recalls

Facilities

Description

The SurgiLight by View Medical is a surgical lighting system that aims to provide surgeons with a safe and practical illumination device to focus on specific target areas. It mounts to the handle attachment anchor point of various overhead surgical lights, and features a long, flexible shaft that will allow the user to direct the light onto the incision from any desired angle. The View Medical SurgiLight shall be used in conjunction with the sterile Disposable Handle Assembly.

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.