BEUDAMED
    FDA Recall Terminated

    AS-OBGYN Information System version 7.824.x

    Recall: Z-0118-2019 · Initiated September 20, 2018

    Recall

    Recall Number
    Z-0118-2019
    Event Number
    81057
    Firm
    AS Software, Inc.
    FEI Number
    3005207094
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 20, 2018
    Terminated
    April 19, 2019
    Address
    560 Sylvan Ave, Englewood Cliffs, NJ, 07632-3119

    Description

    AS-OBGYN Information System version 7.824.x

    Reason

    Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that ultrasound measurements are crossing over correctly to the AS system

    Action

    AS Software issued letter by email on 9/20/18 to notify customers that any change made to their ultrasound machine such as software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, are tested prior to the use in the production environment. Medical Device Correction Return Response form to be signed and returned. The AS Software Support Department can be reached Monday through Friday, 9:00 AM to 6:00 PM EST via phone: 201-541-1900 option 2 or e-mail: [email protected]

    Distribution

    US Nationwide.

    Quantity

    52 systems