BEUDAMED
    FDA Recall Terminated

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    Recall: Z-1061-2015 · Initiated January 9, 2015

    Recall

    Recall Number
    Z-1061-2015
    Event Number
    70238
    Firm
    Alltech Medical Systems America Inc
    FEI Number
    3007138967
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 9, 2015
    Posted
    February 18, 2015
    Terminated
    September 15, 2015
    Address
    28900 Fountain Pkwy, Solon, OH, 44139-4383

    Description

    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.

    Reason

    The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.

    Action

    Altech Medical Systems America Inc., notified customers on January 9, 2015, of the problem via telephone. Customers were instructed to immediately cease using the product until the correction can be made. A follow-up letter was sent through the mail, which stated that a service engineer would make a site visit to ramp down the magnet until the issue can be corrected. Customers were asked to complete the attached Acknowledgement and Receipt Form and fax it to (440) 424-2255. For questions contact AMSA at 1-855-200-2672.

    Distribution

    US Distribution in the state of Maryland.

    Quantity

    2 units