Medical device recalls Moderate risk

Skytron, Div. The KMW Group, Inc recalls VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration…

Recall date
September 11, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0071-2021
FDA classification
Class II
Brand / firm
Skytron, Div. The KMW Group, Inc
Sold / distributed
AZ, MI, MS, NJ, PA,

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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