BEUDAMED
    FDA Recall Terminated

    Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.

    Recall: Z-0364-2008 · Initiated March 21, 2007

    Recall

    Recall Number
    Z-0364-2008
    Event Number
    38346
    Firm
    Accuray Inc
    FEI Number
    1000123585
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 21, 2007
    Posted
    December 12, 2007
    Terminated
    December 26, 2007
    Address
    1310 Chesapeake Ter, Sunnyvale, CA, 94089-1100

    Description

    Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.

    Reason

    Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.

    Action

    The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or [email protected].

    Distribution

    Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.

    Quantity

    25 units