BEUDAMED
    FDA Recall Terminated

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    Recall: Z-1615-2018 · Initiated February 15, 2017

    Recall

    Recall Number
    Z-1615-2018
    Event Number
    79830
    Firm
    IntroMedic Co., Ltd. F-Rtek 6 Floor 11-25 Simindaero327beon-Gil; Dongan Anyang Korea (the Republic of)
    FEI Number
    3013489112
    Product Code
    NEZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 15, 2017
    Terminated
    August 8, 2018

    Description

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    Reason

    When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.

    Action

    Intromedic representatives visited hospitals with the affected products after the first awareness of the problem in order to explain the corresponding issue to our distributor in USA and gave them training on how to check the software before and after the software update. Firm revisited the hospitals in which the software was not conducted by our distributor and carried out the software update since Nov 13th, 2017. The software update was not made immediately as we believe that the reoccurrence possibility of this issue is very low since have not received any other report of the issue from USA and other countries, and the receiver works fine after it is turned off and on again. Some of the hospitals visited refused to conduct software update while being aware of the issue as they were not encountered with the issue. The remaining hospitals in which software update is not conducted will be visited and software update will be conducted by firm's distributor by April.

    Distribution

    Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC

    Quantity

    82