BEUDAMED
    FDA Recall Terminated

    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

    Recall: Z-1027-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-1027-2016
    Event Number
    72976
    Firm
    NeoCoil, LLC
    FEI Number
    3006369484
    Product Code
    MOS
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 18, 2015
    Terminated
    October 12, 2016
    Address
    N27W23910 Paul Rd, Ste A, Pewaukee, WI, 53072-6204

    Description

    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

    Reason

    Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

    Action

    Distributor was sent a NeoColi "Urgent Medical Device Recall" letter dated 18 December 2015. The letter described the problem and the product involved in the recall. Consignee was advised to quarantine the product and to identify their customers and provide a list to NeoCoil. NeoCoil will contact each customer for correction and removal of the devices. Requested consignee to complete and return the response form. For questions call Michael Leigh at 261-522-6127.

    Distribution

    US Nationwide Distribution

    Quantity

    2121