Skytron, Div. The KMW Group, Inc recalls SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained vide…

Recall date

March 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0109-2021

FDA classification

Class II

Brand / firm

Skytron, Div. The KMW Group, Inc

Sold / distributed

US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.