BEUDAMED
    FDA Recall Open, Classified

    MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).

    Recall: Z-2040-2024 · Initiated April 15, 2024

    Recall

    Recall Number
    Z-2040-2024
    Event Number
    94557
    Firm
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel
    FEI Number
    3004571294
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 15, 2024
    Posted
    June 7, 2024

    Description

    MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).

    Reason

    There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

    Action

    The recalling firm issued letters on and dated 4/15/2024 via FedEx informing the consignee of the safety issue and actions to be taken by the customer/user. The actions state the consignee can continue to use the system but until GE HealthCare implements the correction for this potential issue on the affected device and before conducting any servicing activities that involve movement of the covers, GE HealthCare Service should be contacted for guidance. An acknowledgement form was enclosed for completion and return. The letter contained an embedded photograph of the device showing where to find the manufacturing date to determine if it is an affected device. The letter also informs the consignee they will be contacted by a GE HealthCare representative to arrange for the correction.

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, NC, ND, NV, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Belgium, Brazil, Canada, Czech Republic, Finland, France, India, Israel, Italy, Japan, Malaysia, Malta, Poland, Singapore, Spain, Taiwan, Turkey, and United Kingdom.

    Quantity

    133 devices