BEUDAMED
    FDA Recall Terminated

    Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.

    Recall: Z-0258-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0258-2007
    Event Number
    36596
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    December 15, 2006
    Terminated
    June 20, 2007
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use with Braun IBP Transducers. The product is an accessory to patient physiological monitor.

    Reason

    Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.

    Action

    The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling.

    Distribution

    Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan.

    Quantity

    80 units