Z-0071-2021Class II

VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300...

Name: Z-0071-2021 VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300...
Creator: Skytron, Div. The KMW Group, Inc
Published: 2020-09-11
License: https://open.fda.gov/license/

Skytron, LLC / initiated 2020-09-11 / Terminated / root cause: software

FDA source

Skytron, Div. The KMW Group, Inc began a recall of 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... on 2020-09-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0071-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-11
Posted: 2020-10-08
Terminated: 2024-09-24
Recalling firm: Skytron, LLC
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.
Product code: LMD System, Digital Image Communications, Radiological
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
Root cause tag: software
FDA 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. ([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
Quantity in commerce: 11 units
Distribution: AZ, MI, MS, NJ, PA,
Product codes and lots: Serial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0071-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0071-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code LMD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)