FDAMarch 10, 2020device

SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happen during a case, cause increase risk to patient due to hospital losing the visual image.

What to do

FDA enforcement status: Terminated

Brands named

skytron div the kmwskytronskytron div

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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