FDA recall Z-0109-2021

Skytron, Div. The KMW Group, Inc · Class II · device

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.

Reason for recall

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2020-03-10
Report date: 2020-10-21
Termination date: 2021-06-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2021