BEUDAMED
    FDA Recall Terminated

    RAPIDPoint 500 Blood Gas Analyzer with v2.4 software 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. Siemens SMN numbers: 10492730, 10696857, 10697306

    Recall: Z-2040-2017 · Initiated April 10, 2017

    Recall

    Recall Number
    Z-2040-2017
    Event Number
    76981
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 10, 2017
    Terminated
    August 20, 2019
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    RAPIDPoint 500 Blood Gas Analyzer with v2.4 software 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. Siemens SMN numbers: 10492730, 10696857, 10697306

    Reason

    Potential Patient Demographic Error with Blank Patient ID Field

    Action

    Siemens Healthcare issued an An Urgent Field Safety Notice via e-mail to all affected Siemens Healthcare Diagnostics Regional offices on April 10, 2017 both in the United States and outside of the United States. This notice informs customers of the issue, risk to health and actions to be taken by the customer. A Field Correction Effectiveness Check form to be completed and returned. Questions: Contact your Siemens Customer Care Center or your local Siemens technical support representative

    Distribution

    Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay

    Quantity

    159 units