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.
Recall
- Recall Number
- Z-0109-2021
- Event Number
- 86439
- Firm
- Skytron, Div. The KMW Group, Inc
- FEI Number
- 1825014
- Product Code
- LMD
- Status
- Terminated
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- March 10, 2020
- Terminated
- June 1, 2021
- Address
- 5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512-5515
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.
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.
Skytron Authorized Representatives contacted the affected facilities beginning on 3/4/20 via phone or in person .Skytron Authorized Representatives visited sites to correct the issue wih the following message: Skytron, LLC is voluntarily recalling a limited number of SDS integration units. The SDS router may experience an intermittent issue related to display output functionality. This failure poses a potential safety risk to patients. This firmware update is being conducted to correct the failure.
US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
36 units