BEUDAMED
    FDA Recall Terminated

    STREAMLAB CORE UNIT / LYNX WITH IOM

    Recall: Z-0215-2019 · Initiated August 14, 2018

    Recall

    Recall Number
    Z-0215-2019
    Event Number
    81047
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    LXG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 14, 2018
    Terminated
    September 4, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    STREAMLAB CORE UNIT / LYNX WITH IOM

    Reason

    The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

    Action

    Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers.

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.

    Quantity

    186 StreamLAB Automation Modules