BEUDAMED
    FDA Recall Terminated

    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

    Recall: Z-1606-2015 · Initiated May 4, 2015

    Recall

    Recall Number
    Z-1606-2015
    Event Number
    71211
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 4, 2015
    Posted
    May 12, 2015
    Terminated
    September 15, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

    Reason

    The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment

    Action

    GE Healthcare sent an Urgent Medical Device Correction letter dated May 1, 2015, to all affected consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM.

    Quantity

    110 (83 units US, 27 units OUS)