BEUDAMED
    FDA Recall Terminated

    Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system

    Recall: Z-1834-2011 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-1834-2011
    Event Number
    54706
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2937457
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 6, 2009
    Posted
    March 28, 2011
    Terminated
    April 6, 2011
    Address
    4040 Nelson Ave, Concord, CA, 94520-1200

    Description

    Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system

    Reason

    A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs at Risk) the user only defines the max. dose. The firms engineering team determined that the software defect was repeatable.

    Action

    Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.

    Distribution

    Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.

    Quantity

    60 units