BEUDAMED
    FDA Recall Terminated

    Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.

    Recall: Z-1195-2007 · Initiated April 18, 2007

    Recall

    Recall Number
    Z-1195-2007
    Event Number
    38349
    Firm
    Varian Medical Systems Inc
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 18, 2007
    Posted
    August 29, 2007
    Terminated
    August 12, 2010
    Address
    911 Hansen Way, Palo Alto, CA, 94304

    Description

    Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.

    Reason

    Patient positioning errors may occur because of mechanical variations during product installation.

    Action

    The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.

    Distribution

    Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.

    Quantity

    291 units