BEUDAMED
    FDA Enforcement Class III Terminated

    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    Recall: Z-2601-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2601-2016
    Event ID
    74564
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2016
    Initiation Date
    July 5, 2016
    Classification Date
    August 19, 2016
    Termination Date
    August 2, 2017
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637, United States

    Description

    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    Reason

    Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States

    Code Info

    Software Version 2.2A

    Distribution

    Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA

    Quantity

    76