Reported Oct 21, 2020 · Terminated
SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained…
Skytron, Div. The KMW Group, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Skytron, Div. The KMW Group, Inc · 5085 Corporate Exchange Blvd SE · Grand Rapids, MI · 49512-5515
Is this the product you have?
- SkyVision
- SDS System - Video Integration ModelGC-SDS-BSCB-200 -
- Product Usageis a high quality, self-contained video switching and control unit for use in the operating room
- Lot codes and dates
- Serial Numbers
DIPSG212460015DIPSG212510043DIPSG213160042DIPSG214480117DIPSG215040016DIPSG219380004DIPSG219380005DIPSG219380006DIPSG219380007DIPSG219380008DIPSG219380013DIPSG219380014DIPSG219380015DIPSG219380016DIPSG219380017DIPSG219380018DIPSG219380019DIPSG219380020DIPSG219380021DIPSG219380022DIPSG219380023DIPSG219380024DIPSG219380025DIPSG219380026DIPSG219420002DIPSG219420003DIPSG219420004DIPSG219420005DIPSG219420006DIPSG219420007DIPSG219470004DIPSG219470008DIPSG219470011DIPSG219470013DIPSG219470014DIPSG219490014
- Serial Numbers
- Amount recalled
- 36 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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