BEUDAMED
    FDA Recall 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 · Initiated May 22, 2014

    Recall

    Recall Number
    Z-2071-2014
    Event Number
    68353
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 22, 2014
    Posted
    July 17, 2014
    Terminated
    May 26, 2015
    Address
    2 Edgewater Drive, Norwood, MA, 02062

    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

    Action

    Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 22, 2014, both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDComm Data Management System (Version 5.0.A software correction will be issued to address the problem. Please retain this letter with your laboratory records. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (781) 269-3000.

    Distribution

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

    Quantity

    6 systems