Events

Device Recall MiroCam Capsule Endoscope Syste 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 IntroMedic Co., Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79830
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1615-2018
  • 사례 시작날짜
    2017-02-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163624
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    System, imaging, gastrointestinal, wireless, capsule - Product Code NEZ
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    None
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Us Nationwide Distribution in the states of: NY, MD, TX, IL, IN, KY, FL, OH, TN, CA, GA, KS, MO & NC
  • 제품 설명
    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.
  • 제조사 주소
    IntroMedic Co., Ltd., F-Rtek 6 Floor, 11-25 Simindaero327beon-Gil; Dongan, Anyang Korea (the Republic of)
  • 제조사 모회사 (2017)
    IntroMedic Co., Ltd.
  • Source
    USFDA