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U.S. Department of Health and Human Services

Class 2 Device Recall SkyVision SDS

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  Class 2 Device Recall SkyVision SDS see related information
Date Initiated by Firm March 10, 2020
Create Date October 15, 2020
Recall Status1 Terminated 3 on June 01, 2021
Recall Number Z-0109-2021
Recall Event ID 86439
Product Classification System, digital image communications, radiological - Product Code LMD
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
For Additional Information Contact SAME
616-656-2900
Manufacturer 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.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
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.
Quantity in Commerce 36 units
Distribution US Nationwide distribution including in the states of CA, FL, IA, MI, MN, NY, PA, TX, WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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