BEUDAMED
    FDA Recall Terminated

    EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787

    Recall: Z-1391-2012 · Initiated December 2, 2011

    Recall

    Recall Number
    Z-1391-2012
    Event Number
    61347
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 2, 2011
    Posted
    April 10, 2012
    Terminated
    March 21, 2014
    Address
    500 GBC Drive PO BOX 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787

    Reason

    QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused.

    Action

    Siemens Healthcare Diagnostic Inc, sent a Urgent Field Safety Notice dated December 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to follow these instructions. The first option is Extending the "Minimum Inactive Days" to 999 days. The second option is to proactively monitor the system for unexpected Pending QC Controls. Long Term Action Plan: A corrective and preventive action (CAPA) investigation has been issued. Currently firm is actively investigating. Further questions please call (302) 631-0516.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN.

    Quantity

    787