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U.S. Department of Health and Human Services

Class 2 Device Recall SkyVision Linx 300

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  Class 2 Device Recall SkyVision Linx 300 see related information
Date Initiated by Firm September 11, 2020
Create Date October 08, 2020
Recall Status1 Open3, Classified
Recall Number Z-0071-2021
Recall Event ID 86474
Product Classification System, digital image communications, radiological - Product Code LMD
Product VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System
Model: VGDF-SKY (version 2). For communication and visual image management in the operating room suite.
Code Information Serial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771 
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		 VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
FDA Determined
Cause 2		 Software design
Action Skytron notified authorized representatives on September 11, 2020 via email states reason for recall and action to take: Please let us know if you have deployed these into a facility. We will provide new replacement VGA faceplates. Skytron is scheduled to receive the replacements from Opticis by Oct 12. Process: 1.)Please enter a no charge PO and you will receive an RMA for the faceplates. (returns@skytron.us) 2.)Skytron will send new faceplates. 3.)Complete & return the attached acknowledgement form. (This is an FDA recall and paperwork is essential!) 4.)Return original VGA faceplate to Skytron. The Customer Acknowledgement form states reason and health risk and will be completed for each facility signed by the Distributor Representative and Customer
Quantity in Commerce 11 units
Distribution AZ, MI, MS, NJ, PA,
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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