Recall Z-0109-2021 ยท LMD System, Digital Image Communications, Radiological
Skytron, Div. The KMW Group, Inc
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.
| Date | Mar 10, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | 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. |
| Quantity | 36 units |
| Distribution | US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.