BEUDAMED
    FDA Recall Terminated

    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.

    Recall: Z-1974-2010 · Initiated April 15, 2010

    Recall

    Recall Number
    Z-1974-2010
    Event Number
    55598
    Firm
    McKesson Provider Technologies Medical Imaging Group
    FEI Number
    3005157178
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    April 15, 2010
    Posted
    July 9, 2010
    Terminated
    July 21, 2010
    Address
    1639 State Rt 10, Ste 100, Parsippany, NJ, 07054-4506

    Description

    Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro PB 1000 Monitor unit.

    Reason

    McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cariology Hemo Real Time Monitor Screen.

    Action

    The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.

    Distribution

    Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX .

    Quantity

    26 units; 19 in operational use, 8 as emergency replacement units.