Recall Z-0071-2021 ยท LMD System, Digital Image Communications, Radiological
Skytron, Div. The KMW Group, Inc
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.
| Date | Sep 11, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 Sky |
| Quantity | 11 units |
| Distribution | AZ, MI, MS, NJ, PA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.