BEUDAMED
    FDA Recall Terminated

    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

    Recall: Z-1944-2014 · Initiated May 20, 2014

    Recall

    Recall Number
    Z-1944-2014
    Event Number
    68394
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 20, 2014
    Posted
    June 30, 2014
    Terminated
    August 10, 2015
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    Description

    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

    Reason

    Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

    Action

    An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.

    Distribution

    Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.

    Quantity

    336