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.
FDA Recall Z-0071-2021 · Posted None
Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusTerminated
Product CodeLMD
Date Initiated2020-09-11
Date Terminated2024-09-24
Product Quantity11 units
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
Firm 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. ([email protected])
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
Root Cause
Software design
Distribution Pattern
AZ, MI, MS, NJ, PA,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.