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.
- Company
- Skytron, Div. The Kmw Group, Inc
- Recall Initiated
- September 11, 2020
- Terminated
- September 24, 2024
- Recall Number
- Z-0071-2021
- Quantity
- 11 units
- Firm Location
- Grand Rapids, MI
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
Distribution
AZ, MI, MS, NJ, PA,
Lot / Code Info
Serial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771
Root Cause
Software design
Action Taken
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