BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0071-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0071-2021
    Event ID
    86474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skytron, Div. The KMW Group, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 14, 2020
    Initiation Date
    September 11, 2020
    Classification Date
    October 8, 2020
    Termination Date
    September 24, 2024
    Address
    5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, 49512-5515, United States

    Description

    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

    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 Info

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

    Distribution

    AZ, MI, MS, NJ, PA,

    Quantity

    11 units