BEUDAMED
    FDA Recall Terminated

    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

    Recall: Z-2151-2011 · Initiated March 23, 2011

    Recall

    Recall Number
    Z-2151-2011
    Event Number
    58441
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    LMB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2011
    Posted
    May 6, 2011
    Terminated
    April 19, 2012
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system

    Reason

    There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.

    Action

    Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact there Siemens Service Engineer or Application Specialist or contact [email protected]. For questions regarding this recall 925-602-8157.

    Distribution

    Nationwide Distribution.

    Quantity

    47