BEUDAMED
    FDA Recall Terminated

    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

    Recall: Z-0205-2020 · Initiated August 15, 2019

    Recall

    Recall Number
    Z-0205-2020
    Event Number
    83655
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 15, 2019
    Terminated
    May 5, 2022
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

    Reason

    Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

    Action

    Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019. The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email. Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0, which corrects the reported behavior(s). A Mandatory Update (MU) campaign has been launched to install the new SW V on all systems, whether or not they are impacted by these behaviors.

    Distribution

    Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

    Quantity

    166 total US: 15; OUS:151