BEUDAMED
    FDA Recall Terminated

    Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

    Recall: Z-2176-2011 · Initiated March 3, 2011

    Recall

    Recall Number
    Z-2176-2011
    Event Number
    58252
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 3, 2011
    Posted
    May 10, 2011
    Terminated
    June 19, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

    Reason

    The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.

    Action

    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the Optical Guidance Platform (OGP) Instructions For Use on Loading a treatment plan; before positioning the patient, compare the plan details loaded into the OGP with the plan details printed from the treatment planning systems; verify that the patient information, isocenter, gantry and couch angles are identical as requested in the Instructions For Use, and advise the appropriate personnel working in their radiotherapy department of the content of this recall letter. Varian has made changes to the OGP Instructions For Use -Varian strongly recommends you download the most recent version at www.MyVarian.com or request a copy from your local Varian Customer Support District or Regional Manager. Varian also is preparing a software correction which will be applied to affected unites to correct this issue. If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager at the follow: USA and Canada - 1-888-827-4265; Europe +41 41 749 8844; E-mail-North America: [email protected]; Australia/New Zealand: [email protected]; Europe: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected], and Latin America: [email protected]; Internet: Oncology Systems customer site - www.myvarian.com and Varian Medical Systems public site-www.varian.com.

    Distribution

    Worldwide distribution.

    Quantity

    599 units