BEUDAMED
    FDA Recall Open, Classified

    Microsurgical Operating Room Tables;7300B (18-350-70);

    Recall: Z-0566-2021 · Initiated September 11, 2019

    Recall

    Recall Number
    Z-0566-2021
    Event Number
    85442
    Firm
    Mizuho America, Inc.
    FEI Number
    1000159388
    Product Code
    GDC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 11, 2019
    Address
    30057 Ahern Ave, Union City, CA, 94587-1234

    Description

    Microsurgical Operating Room Tables;7300B (18-350-70);

    Reason

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

    Action

    The firm's representatives notified their U.S. consignees regarding the recall notification by phone and a separate FedEx letter was sent (08/09/2019 - date the letter was issued). The Customer Notification Letter "IMPORTANT VOLUNTARY RECALL NOTIFICATION", informed customers of the two (2) types of errors: 1) Unintended Tilting of the Tabletop - Impurities in the hydraulic oil has caused minor leaking inside a control valve causing the table to tilt after remaining static for long periods of time. 2) Incorrect Operation due to Infrared Operating Signal Errors - The table can inadvertently mix infrared signals from the hand pendant while using in the wireless mode and may cause unintended movement. Customer are also being informed that a sales representative will contact them to organize the logistics of the correction for the tables. The recall notification includes to visit the firm's webpage (www.mizuho.com) to find additional information related to the recall. For additional questions, the Customer Service Group or local sales representatives can be contacted.

    Distribution

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

    Quantity

    8