BEUDAMED
    FDA Recall Terminated

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    Recall: Z-2405-2012 · Initiated August 6, 2012

    Recall

    Recall Number
    Z-2405-2012
    Event Number
    62917
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 6, 2012
    Posted
    September 19, 2012
    Terminated
    October 8, 2014
    Address
    4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011

    Description

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    Reason

    There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

    Action

    Elekta sent an Important Field Safety Notice dated August, 2012 to inform users that inspection and possibly bolt replacement needs to be carried out. Users should return the signed acknowledgement to Elketa, and an inspection should be carried out under FCO20002103053. For questions customers should call +44(0)1293 654200. For questions regarding this recall call 770-300-9725.

    Distribution

    Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto

    Quantity

    110