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
    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2021 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.