CLASS II Device recall · Reported 14 Oct 2020 · FDA Enforcement Report

Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format recalled

Skytron, Div. The KMW Group is recalling Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format Faceplate, a component of the, distributed in Arizona, Michigan, Mississippi, New Jersey, Pennsylvania. The recall was initiated on 11 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771

Quantity recalled11 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0071-2021
FDA event ID: 86474
Recalling firm: Skytron, Div. The KMW Group, Grand Rapids, MI
Classification: Class II
Status: Terminated
Recall initiated: 11 Sep 2020
FDA classified: 8 Oct 2020
Reported: 14 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Sep 2020	Recall initiated by company
8 Oct 2020	Classified by FDA	+27 days
14 Oct 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

AZ, MI, MS, NJ, PA,

Arizona Michigan Mississippi New Jersey Pennsylvania

Questions about this recall

Is Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format Faceplate, a component of the recalled?

Yes. Skytron, Div. The KMW Group recalled Vgdf-sky (R4-010-06) Vga TO Fiber Converter-Single Format Faceplate, a component of the on 11 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0071-2021.

Why was it recalled?

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

Which lots are affected?

Serial Numbers: MXDM200501769 MXDM200501773 MXDM191100421 MXDM191100422 MXDM200200161 MXDM200200162 MXDM200200163 MXDM200200164 MXDM200501770 MXDM200501772 MXDM200501771

Where was it sold?

AZ, MI, MS, NJ, PA,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Skytron, Div. The KMW Group

All 9

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1 Apr 2020Device	CLASS II	Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen recalled	Skytron, Div. The KMW Group	Device Malfunction	10 states
19 Jun 2019Device	CLASS II	Skytron Integrity 270 Steam Sterilizer recalled	Skytron, Div. The KMW Group	Sterility	Nationwide

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