BEUDAMED
    FDA Enforcement Class III Terminated

    Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,

    Recall: Z-2071-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2071-2014
    Event ID
    68353
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    May 22, 2014
    Classification Date
    July 17, 2014
    Termination Date
    May 26, 2015
    Address
    2 Edgewater Drive, N/A, Norwood, MA, 02062, United States

    Description

    Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,

    Reason

    RAPIDComm¿ 5.0 Screen Layout will display incorrect test names

    Code Info

    Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

    Distribution

    Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.

    Quantity

    6 systems