BEUDAMED
    FDA Recall Terminated

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    Recall: Z-2312-2016 · Initiated June 17, 2016

    Recall

    Recall Number
    Z-2312-2016
    Event Number
    74477
    Firm
    NeoCoil, LLC
    FEI Number
    3006369484
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 17, 2016
    Terminated
    November 21, 2017
    Address
    N27W23910 Paul Rd, Ste A, Pewaukee, WI, 53072-6204

    Description

    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

    Reason

    There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.

    Action

    NeoCoil sent an "Urgent Medical Device Recall" letter dated 17 June 2016. The letter described the problem and the product involved in the recall. Advised consignee to quarantine the product and if the product was further distributed to identify the customers and provide the list to NeoCoil. The recall will be carried to the user level. Requested consignee to complete and return the response form. For questions call 262-522-6127.

    Distribution

    Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.

    Quantity

    39 (11 US, 28 OUS)