BEUDAMED
    FDA Recall Terminated

    Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Recall: Z-2224-2011 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-2224-2011
    Event Number
    58558
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 31, 2011
    Posted
    May 20, 2011
    Terminated
    March 13, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    Reason

    The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.

    Action

    On 3/31/2011, all consignees were notified via an Urgent Medical Device Correction letter and on-site visit by the firm's sales representative, informing them of the affected products, the issue, and recommended actions. If non-Varian personnel service the device, then they should have been immediately notified of the content of the letter. Anyone who performs work on the device should exercise extreme care to identify any possible coolant leak and immediately locate and correct the source of the leak. Customers were to immediately notify Varian Service or their internal service personnel of any coolant leakage. Varian was to contact customers to arrange for inspection if one had not been performed. The appropriate personnel should have been advised of the content of the letter. If further clarification was needed, customers were to contact their local Varian Customer Support.

    Distribution

    Worldwide Distribution

    Quantity

    718 units