BEUDAMED
    FDA Recall Terminated

    AMSCO 400 and AMSCO C Small Steam Sterilizers

    Recall: Z-0210-2016 · Initiated September 3, 2015

    Recall

    Recall Number
    Z-0210-2016
    Event Number
    72217
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FLE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 3, 2015
    Posted
    November 4, 2015
    Terminated
    January 22, 2016
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    AMSCO 400 and AMSCO C Small Steam Sterilizers

    Reason

    In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.

    Action

    On 9/21/2015 the firm sent Recall Correction Notices to their customers.

    Distribution

    US nationwide distribution.

    Quantity

    32 units