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.
Enforcement
- Recall Number
- Z-0109-2021
- Event ID
- 86439
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Skytron, Div. The KMW Group, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 21, 2020
- Initiation Date
- March 10, 2020
- Classification Date
- October 15, 2020
- Termination Date
- June 1, 2021
- Address
- 5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, 49512-5515, United States
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.
Serial Numbers: DIPSG212460015 DIPSG212510043 DIPSG213160042 DIPSG214480117 DIPSG215040016 DIPSG219380004 DIPSG219380005 DIPSG219380006 DIPSG219380007 DIPSG219380008 DIPSG219380013 DIPSG219380014 DIPSG219380015 DIPSG219380016 DIPSG219380017 DIPSG219380018 DIPSG219380019 DIPSG219380020 DIPSG219380021 DIPSG219380022 DIPSG219380023 DIPSG219380024 DIPSG219380025 DIPSG219380026 DIPSG219420002 DIPSG219420003 DIPSG219420004 DIPSG219420005 DIPSG219420006 DIPSG219420007 DIPSG219470004 DIPSG219470008 DIPSG219470011 DIPSG219470013 DIPSG219470014 DIPSG219490014
US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
36 units