Events

Recall of Device Recall MiroCam Capsule Endoscope Syste

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by IntroMedic Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79830
  • Event Risk Class
    Class 2
  • Event Number
    Z-1615-2018
  • Event Initiated Date
    2017-02-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163624
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
  • 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.

Device

Device Recall MiroCam Capsule Endoscope Syste
  • Model / Serial
    None
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
  • Product 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.
  • Manufacturer
    IntroMedic Co., Ltd.

Manufacturer

IntroMedic Co., Ltd.
  • Manufacturer Address
    IntroMedic Co., Ltd., F-Rtek 6 Floor, 11-25 Simindaero327beon-Gil; Dongan, Anyang Korea (the Republic of)
  • Manufacturer Parent Company (2017)
    IntroMedic Co., Ltd.
  • Source
    USFDA