BEUDAMED
    FDA Recall Open, Classified

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    Recall: Z-1293-2021 · Initiated February 8, 2021

    Recall

    Recall Number
    Z-1293-2021
    Event Number
    87318
    Firm
    Mizuho OSI
    FEI Number
    2921578
    Product Code
    GDC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 8, 2021
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234

    Description

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    Reason

    There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.

    Action

    On 2/3/2021 Mizuho sent a "Recall Notice for Control Unit" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: 1. Identify if you have the affected product, 2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive.

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.

    Quantity

    26 units