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Recall Observatory FDA recall evidence

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.

Z-0071-2021

September 11, 2020

Class II

Product summary

Firm
Skytron, Div. The KMW Group, Inc
Event
Event 86474
Status
Terminated
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-0071-2021

Official wording

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

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

Distribution pattern: AZ, MI, MS, NJ, PA,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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