BEUDAMED
    FDA Recall Terminated

    Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS photon beam, -- Fine Beam Isocenter Accuracy, -- Stereotactic motion disable. ----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA

    Recall: Z-0544-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-0544-2008
    Event Number
    45520
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 10, 2007
    Posted
    February 14, 2008
    Terminated
    November 27, 2010
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS photon beam, -- Fine Beam Isocenter Accuracy, -- Stereotactic motion disable. ----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA

    Reason

    Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

    Action

    On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.

    Distribution

    Worldwide- Canada, Mexico, and the USA

    Quantity

    418 (total for Recalls Z-0544-0545-2008)