FDA recall Z-0071-2021

Skytron, Div. The KMW Group, Inc · Class II · device

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.

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

Distribution

AZ, MI, MS, NJ, PA,

Key facts

Status: Terminated
Initiation date: 2020-09-11
Report date: 2020-10-14
Termination date: 2024-09-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0071-2021