BEUDAMED
    FDA Enforcement Class II Terminated

    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

    Recall: Z-0464-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0464-2015
    Event ID
    69515
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vision Rt Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 3, 2014
    Initiation Date
    October 15, 2014
    Classification Date
    November 25, 2014
    Termination Date
    May 10, 2016
    Address
    8840 Stanford Blvd, N/A, Columbia, MD, 21045-5827, United States

    Description

    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.

    Reason

    Potential failure of AlignRT to assert interlock.

    Code Info

    Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.

    Distribution

    Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.

    Quantity

    7 (Six Units distribited in the US and One in OUS.)