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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
Recalled October 21, 2020 · FDA recall Z-0109-2021 · Skytron, Div. The KMW Group
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. · FDA Class II
Units
36 units
Sold at
US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
Description
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.
Product
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.
Manufacturer(s)
Skytron, Div. The KMW Group, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →