BEUDAMED
    FDA Recall Terminated

    Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.

    Recall: Z-1899-2010 · Initiated January 27, 2010

    Recall

    Recall Number
    Z-1899-2010
    Event Number
    55597
    Firm
    McKesson Provider Technologies Medical Imaging Group
    FEI Number
    3005157178
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 27, 2010
    Posted
    June 24, 2010
    Terminated
    June 25, 2010
    Address
    1639 State Rt 10, Ste 100, Parsippany, NJ, 07054-4506

    Description

    Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.

    Reason

    McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.

    Action

    The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to pleasel immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.

    Distribution

    Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.

    Quantity

    22 devices