BEUDAMED
    FDA Enforcement Class II Terminated

    Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.

    Recall: Z-2243-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2243-2020
    Event ID
    85654
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med Tec Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 10, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    June 2, 2020
    Termination Date
    March 25, 2021
    Address
    1401 8th St Se, N/A, Orange City, IA, 51041-7463, United States

    Description

    Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.

    Reason

    Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.

    Code Info

    Part Number: MTCFHNV UDI: 00841439104156 Lot Numbers: M027990; M505880; M847500; M166160; M505890; M858580; M198170; M505900; M858590; M241650; M505910; M869030; M249180; M511240; M885500; M257630; M530920; M918000; M278760; M541350; M919980; M282330; M553300; M919990; M283380; M553720; M928400; M293670; M553740; M928410; M300750; M596220; M934260; M303010; M596230; M936110; M314410; M616690; M942400; M321880; M616700; M942510; M323560; M649630; M944110; M326580; M649670; M951030; M333420; M649770; M964730; M350700; M715520; M979830; M356130; M715540; M987460; M362290; M743010; M995860; M365740; M767820; M369700; M774760; M371990; M782390; M418080; M796350; M436620; M796360; M439700; M802120; M442410; M805650; M446460; M809050; M448260; M809060; M457870; M820300; M457880; M829290; M462640; M834400; M493710; M844990; M495030; M845000

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of WI, TX, AZ, FL, NE, TN, MA, FL, GA, IN, OR, PA, IL, LA, NH, MS, MI, OH, MN, VA, IA, CA, NC, SC, AK, UT, WA, MO, MT, KS, and WV. The countries of Africa, Colombia, Saudi Arabia, Costa Rica, South Korea, Hungary, Spain, and Italy.

    Quantity

    171 units