BEUDAMED
    FDA Enforcement Class II Terminated

    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    Recall: Z-0673-2016 · Reported January 27, 2016

    Enforcement

    Recall Number
    Z-0673-2016
    Event ID
    72202
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MWT Materials, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 27, 2016
    Initiation Date
    October 6, 2014
    Classification Date
    January 20, 2016
    Termination Date
    July 13, 2021
    Address
    90 Dayton Ave Ste 6E Building 21, N/A, Passaic, NJ, 07055-7014, United States

    Description

    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

    Reason

    When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

    Code Info

    All

    Distribution

    US Nationwide Distribution in the states of NY and MA.

    Quantity

    1 unit