BEUDAMED
    FDA Enforcement Class II Terminated

    Integrity R1.2

    Recall: Z-0724-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0724-2018
    Event ID
    78663
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    November 20, 2017
    Classification Date
    February 26, 2018
    Termination Date
    March 15, 2024
    Address
    Fleming Way, N/A, Crawley, N/A, N/A, United Kingdom

    Description

    Integrity R1.2

    Reason

    Potential for positional errors following automatic table movement (ATM).

    Code Info

    Product code 90I--YE, no serial number

    Distribution

    Distributed domestically to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA AND HERZEGOVINIA, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LAOS, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA SUDAN, SURINAME, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UK, UKRAINE, VENEZUELA, VIETNAM, ZIMBABWE

    Quantity

    539 units total