BEUDAMED
    FDA Recall Terminated

    Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.

    Recall: Z-0076-2011 · Initiated September 2, 2010

    Recall

    Recall Number
    Z-0076-2011
    Event Number
    56736
    Firm
    Impac Medical Systems Inc
    FEI Number
    1000123805
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 2, 2010
    Posted
    October 18, 2010
    Terminated
    June 24, 2011
    Address
    100 Mathilda Pl, Fl 5th, Sunnyvale, CA, 94086-6076

    Description

    Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.

    Reason

    Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.

    Action

    Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672

    Distribution

    Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK.

    Quantity

    797 units