BEUDAMED
    FDA Enforcement Class II Terminated

    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

    Recall: Z-0479-2022 · Reported January 19, 2022

    Enforcement

    Recall Number
    Z-0479-2022
    Event ID
    89314
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PTW NORTH AMERICA CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 19, 2022
    Initiation Date
    August 27, 2021
    Classification Date
    January 11, 2022
    Termination Date
    February 9, 2024
    Address
    6 Mars Ct Rm Unit 5, N/A, Boonton, NJ, 07005-9309, United States

    Description

    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

    Reason

    When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results

    Code Info

    S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust

    Distribution

    US Nationwide distribution in the state of CO.

    Quantity

    1 unit