BEUDAMED
    FDA Recall Terminated

    Atellica IM 1600 Analyzer, Material Number 11066000

    Recall: Z-1300-2019 · Initiated March 7, 2019

    Recall

    Recall Number
    Z-1300-2019
    Event Number
    82602
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 7, 2019
    Terminated
    August 20, 2020
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica IM 1600 Analyzer, Material Number 11066000

    Reason

    There were multiple issues identified in the system software which required an update.

    Action

    Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.

    Distribution

    The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.

    Quantity

    366