BEUDAMED
    FDA Recall Terminated

    Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)

    Recall: Z-0194-2007 · Initiated August 31, 2006

    Recall

    Recall Number
    Z-0194-2007
    Event Number
    36555
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 31, 2006
    Posted
    November 16, 2006
    Terminated
    December 4, 2007
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)

    Reason

    The chain holding the device gantry in position may break.

    Action

    On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

    Distribution

    Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colombia, China, Canada, Belgium, Australia and Venezuela.

    Quantity

    254 units