BEUDAMED
    FDA Enforcement Class II Ongoing

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    Recall: Z-1665-2023 · Reported June 7, 2023

    Enforcement

    Recall Number
    Z-1665-2023
    Event ID
    92270
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 7, 2023
    Initiation Date
    May 5, 2023
    Classification Date
    May 30, 2023
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    Description

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    Reason

    A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

    Code Info

    Varex Part Number 95510354H-01 (Varex serial numbers 354-01H_A0010004PC to 354-01H_A0010269PC). a. Elekta Infinity: UDI-DI Number: 05060191071543, 05060191071512 (Serial Numbers: 156073, 152223, 153681); b. Versa HD: UDI-DI Number: 05060191071574, 05060191071529 (Serial Numbers: 156941, 156989, 156724, 156998); c. Elekta Synergy: UDI-DI Number: 05060191071550, 05060191071505 (Serial Number: 152483) Additional serial numbers distributed OUS: 109331, 109333, 109335, 109336, 109339, 109341, 109342, 151879, 152194, 153038, 153299, 153410, 153970, 156841, 156849, 156966, 156968, 156969, 156970, 156971, 156973, 156977, 156978, 156979, 156980, 156981, 156982, 156983, 156984, 156985, 156986, 156987, 156988, 156990, 156992, 156995, 156996, 156997.

    Distribution

    Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.

    Quantity

    46 units