BEUDAMED
    FDA Recall Terminated

    Hitachi Altaire Magnetic Resonance Imaging System

    Recall: Z-1103-06 · Initiated January 27, 2006

    Recall

    Recall Number
    Z-1103-06
    Event Number
    34856
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2006
    Posted
    June 10, 2006
    Terminated
    November 13, 2008
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Hitachi Altaire Magnetic Resonance Imaging System

    Reason

    Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.

    Action

    The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.

    Distribution

    Nationwide-The device was distributed to consignees located throughout the United States.

    Quantity

    213 devices have been distributed and installed.