FDA-Device2020-10-21Class II
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.
Skytron, Div. The KMW Group, Inc
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.
Sold states
US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
Affected count
36 units
Manufactured in
5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2021Don't want to check this manually?
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