BEUDAMED
    FDA Enforcement Class II Terminated

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    Recall: Z-1899-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1899-2020
    Event ID
    85269
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 13, 2020
    Initiation Date
    August 12, 2019
    Classification Date
    May 5, 2020
    Termination Date
    January 21, 2021
    Address
    911 Hansen Way, N/A, Palo Alto, CA, 94304-1028, United States

    Description

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    Reason

    After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.

    Code Info

    Model Number(s): product code: H54 and H56; MLC software version 8.5. UDIs: HD 120 MLC Head Assembly. UDI: 00899475002318 80 Leaf Assy, MLC Head, UDI: 00899475002325 120 Leaf Assy, MLC Head, UDI: 00899475002332

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of TN, FL, IN, PA, NV, WA, DC, CA, AL, IL, MD, VA, TX, MN, AR, GA, OR, MS, MO, NY, SC, DE, AZ, NH, MI, NC, OH, PA and OK. The country of Canada.

    Quantity

    151 units