BEUDAMED
    FDA Recall Terminated

    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

    Recall: Z-0777-05 · Initiated February 4, 2005

    Recall

    Recall Number
    Z-0777-05
    Event Number
    31234
    Firm
    Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 4, 2005
    Posted
    April 27, 2005
    Terminated
    August 17, 2006

    Description

    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

    Reason

    Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

    Action

    On 2/4/05, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the device correction.

    Distribution

    The firm has indicated that product was released for distribution to 143 direct consignees in US and to 25 foreign countries via international distribution centers. Foreign distribution include: Australia, Bahrain, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Iceland, India, Israel, Italy, Japan, Kazakhstan, Latvia, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    170 units