BEUDAMED
    FDA Recall Terminated

    Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts.

    Recall: Z-1263-2007 · Initiated July 30, 2007

    Recall

    Recall Number
    Z-1263-2007
    Event Number
    44702
    Firm
    Hitachi Medical Systems America Inc
    FEI Number
    1528028
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2007
    Posted
    September 26, 2007
    Terminated
    October 5, 2010
    Address
    1959 Summit Commerce Park, Twinsburg, OH, 44087-2371

    Description

    Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts.

    Reason

    Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.

    Action

    On 7/30/07, Hitachi sent a Device Correction letter via courier with receipt tracking to all affected customers outlining the risk of overheating of the cable balun assembly and subsequent risk of patient/operator injury. The letter notifies customers that (1) Hitachi will be contacting them in the future to schedule an on-site visit for replacement of the Altaire Shoulder Coil; (2) the replacement will begin in September, 2007 and continue until all affected coils are replaced; and (3) customers that have noticed overheating of the cable balun assembly are urged to notify Hitachi for immediate replacement service.

    Distribution

    Nationwide: U.S. A. to include: AL, AR, AZ, CA, CO, CT, DE, FL, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WY.

    Quantity

    273