BEUDAMED
    FDA Enforcement Class II Terminated

    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

    Recall: Z-1440-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1440-2020
    Event ID
    84957
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invivo Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 11, 2020
    Initiation Date
    February 6, 2020
    Classification Date
    March 4, 2020
    Termination Date
    May 4, 2022
    Address
    3545 SW 47th Ave, N/A, Gainesville, FL, 32608-7691, United States

    Description

    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

    Reason

    Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

    Code Info

    9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI

    Distribution

    U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.

    Quantity

    75