BEUDAMED
    FDA Enforcement Class II Terminated

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    Recall: Z-0792-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0792-2016
    Event ID
    72937
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mizuho OSI
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 17, 2016
    Initiation Date
    December 14, 2015
    Classification Date
    February 9, 2016
    Termination Date
    February 10, 2016
    Address
    30031 Ahern Ave, N/A, Union City, CA, 94587-1234, United States

    Description

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    Reason

    Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.

    Code Info

    Model numbers 7803, 7803AP. Serial numbers 228-261.

    Distribution

    US, South Africa, Japan and United Arab Emirates.

    Quantity

    33