BEUDAMED
    FDA Enforcement Class II Terminated

    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

    Recall: Z-2580-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2580-2021
    Event ID
    88604
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biodex Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 6, 2021
    Initiation Date
    August 16, 2021
    Classification Date
    September 27, 2021
    Termination Date
    May 30, 2024
    Address
    20 Ramsey Rd, N/A, Shirley, NY, 11967-4704, United States

    Description

    Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.

    Reason

    When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration

    Code Info

    Serial Number range:17081557-21062362 UDI: 00718175003305

    Distribution

    Nationwide Foreign: Austria Autralia Brazil CANADA Chile Colombia Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt France Hong Kong HUNGARY Iceland India Iraq Ireland ISRAEL Isreal Italy Japan JORDAN Kuwait Lebanon Libya Malaysia MALTA Mexico Morocco Netherlands New Zealand Oman Pakistan Palestine Panama Peru Philippines Poland Portugal PR Puerto Rico Qatar Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan UAE United Arab Emirates United Kingdom Venezuela

    Quantity

    829 units