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.
FDA Recall Z-0109-2021 · Posted None
Advertisement
Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusTerminated
Product CodeLMD
Date Initiated2020-03-10
Date Terminated2021-06-01
Product Quantity36 units
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.
Firm 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.
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement