Recall Z-0109-2021— Skytron, Div. The KMW Group, Inc
Class II · Terminated
Class II FDA medical device recall by Skytron, Div. The KMW Group, Inc, initiated 2020-03-10, terminated 2021-06-01. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-10
- Terminated
- 2021-06-01
- Firm location
- Grand Rapids, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.