Events

Device Recall SUPERA VERITAS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 IDEV Technologies, Inc. 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
    65245
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1550-2013
  • 사례 시작날짜
    2012-05-29
  • 사례 출판 날짜
    2013-06-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118359
  • 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
    Catheter, biliary, diagnostic - Product Code FGE
  • 원인
    There was an error on the outer labeling of this device. the inner label was correct.
  • 조치
    The firm decided to rework the products that were in their control at the time and the one that was not in their control was corrected by an IDEV employee. That hospital was called and notified of the situation in May 2012.

Device

Device Recall SUPERA VERITAS
  • 모델명 / 제조번호(시리얼번호)
    Model Number: S-05-100-120-G3; Lot Number 01049037
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to the states of FL, NY, and PA.
  • 제품 설명
    IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
  • Manufacturer
    IDEV Technologies, Inc.

Manufacturer

IDEV Technologies, Inc.
  • 제조사 주소
    IDEV Technologies, Inc., 253 Medical Center Blvd, Webster TX 77598-4213
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA