BEUDAMED
    FDA Enforcement Class II Terminated

    IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

    Recall: Z-0959-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0959-2015
    Event ID
    69751
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sun Nuclear Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 21, 2015
    Initiation Date
    August 8, 2014
    Classification Date
    January 13, 2015
    Termination Date
    March 23, 2015
    Address
    3275 Suntree Blvd, Melbourne, FL, 32940-7514, United States

    Description

    IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

    Reason

    Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.

    Code Info

    Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003

    Distribution

    Distributed in the states of CA, CO, and OH.

    Quantity

    6 Units.