BEUDAMED
    FDA Recall Terminated

    Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology departments clinical and business information.

    Recall: Z-0713-2012 · Initiated December 16, 2011

    Recall

    Recall Number
    Z-0713-2012
    Event Number
    60830
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2011
    Posted
    January 11, 2012
    Terminated
    August 6, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, Model Number: HIT, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Product Usage: The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology departments clinical and business information.

    Reason

    Varian received customer complaints involving ARIA Oncology Information Systems, where the Planned Total Dose did not calculate correctly in Physicians Intent. It was identified that incorrect values were being stored for Planned No. Fractions, leading to an unexpected calculation.

    Action

    Varian sent an "Urgent Medical Device Correction - Urgent Field Safety Notice" letter dated December 16, 2011 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the product, problem and recommended user actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems. For questions contact your Varian Customer Support District or Reginal Manager.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    2235 units***12-12-12 AMENDED TO: 2984 units***