BEUDAMED
    FDA Recall Terminated

    SWIN 2017 database, Model YSW4000

    Recall: Z-1939-2020 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-1939-2020
    Event Number
    84764
    Firm
    Remel Inc.
    FEI Number
    1000515493
    Product Code
    LON
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 4, 2019
    Terminated
    August 17, 2020
    Address
    1 Thermo Fisher Way, Oakwood Village, OH, 44146-6536

    Description

    SWIN 2017 database, Model YSW4000

    Reason

    Potential for out of range microbial results

    Action

    Technicians replaced YSW514-17 with YSW514-17A.

    Distribution

    ...

    Quantity

    250