BEUDAMED
    FDA Recall 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 · Initiated August 8, 2014

    Recall

    Recall Number
    Z-0959-2015
    Event Number
    69751
    Firm
    Sun Nuclear Corporation
    FEI Number
    1038814
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    August 8, 2014
    Posted
    January 13, 2015
    Terminated
    March 23, 2015
    Address
    3275 Suntree Blvd, Melbourne, FL, 32940-7514

    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.

    Action

    Sun Nuclear Corp. sent a memo dated 08/08/2014 to their 3 customers of the possible manufacturing error.

    Distribution

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

    Quantity

    6 Units.