BEUDAMED
    FDA Recall Completed

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    Recall: Z-2489-2023 · Initiated August 3, 2023

    Recall

    Recall Number
    Z-2489-2023
    Event Number
    92772
    Firm
    Accuray Incorporated
    FEI Number
    3003873069
    Product Code
    IYE
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    August 3, 2023
    Posted
    August 31, 2023
    Address
    1240 Deming Way, Madison, WI, 53717-1954

    Description

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    Reason

    It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.

    Action

    The recalling firm began issuing letters dated 7/19/2023 via hand-delivery by the field service engineer. The letter explained the issue and explained that if their Radixact System is being serviced by a third-party provider, please ensure they are also aware and take relevant precautions while servicing the system. The product impacted by the issue was detailed. The letter explained the issue arises only during the servicing of the Radixact System and customers can continue the clinical use of their system. The letter informs the consignee that Accuray will inspect the upper roller bracket of each impacted Radixact system to confirm there is adequate clearance for a jib crane. If there is sufficient clearance, then no action is necessary. If there is insufficient clearance, then the old bracket will be replaced with the new bracket following the released updated service procedures. An acknowledgment form was enclosed documenting the consignee confirms understanding the content of the field safety notice and has distributed the information to all applicable members of their staff.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, GA, IL, LA, NJ, OR, PA, SC, SD, TX, and WA. There was government distribution and no military distribution. The countries of Australia, Belgium, Canada, Colombia, France, India, Indonesia, Italy, Japan, Kazakhstan, Malaysia, Poland, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

    Quantity

    82