SkyVision SDS System - Video Integration recall
SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit…
Why was SkyVision SDS System - Video Integration recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit…
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Quantity
- 36 units
- Distribution
- US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
- Recall date
- October 21, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)