BEUDAMED
    FDA Enforcement Class II Ongoing

    Microsurgical Operating Room Tables;7300BX (18-351-70).

    Recall: Z-0567-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0567-2021
    Event ID
    85442
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mizuho America, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 23, 2020
    Initiation Date
    September 11, 2019
    Classification Date
    December 14, 2020
    Address
    30057 Ahern Ave, N/A, Union City, CA, 94587-1234, United States

    Description

    Microsurgical Operating Room Tables;7300BX (18-351-70).

    Reason

    Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

    Code Info

    Tilt Movement-Leaking Valve (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017 & MUC-2018Y-0018. Unintended movement due to infrared signal errors (7300BX-18-351-70) serial numbers: MUC-20163-0001, MUC-2016Z-0002, MUC-2016Z-0003, MUC-20177-0005, MUC-20177-0007, MUC-20177-0008, MUC-20177-0009, MUC-20189-0017, MUC-2018Y-0018 & MUC-2018Y-0019.

    Distribution

    US: AZ, CA, FL, MO, NC, OH, PA, TX, and WI. OUS: Greece, Israel, Japan, and Ukraine.

    Quantity

    10