Events

Device Recall Medtronic Bravo 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Gastroenterology / Urology 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
    28253
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0633-04
  • 사례 시작날짜
    2004-02-06
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31446
  • 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
    Probe And Director, Gastro-Urology - Product Code FGM
  • 원인
    The product's rear panel label could smear during use causing the serial number to be unreadible. this has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
  • 조치
    Letters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.

Device

Device Recall Medtronic Bravo
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers less than 400,000 are involved.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    The devices were distributed nationwide in the United States and worldwide.
  • 제품 설명
    Bravo pH Monitoring System Receiver
  • Manufacturer
    Medtronic Gastroenterology / Urology

Manufacturer

Medtronic Gastroenterology / Urology
  • 제조사 주소
    Medtronic Gastroenterology / Urology, 4000 Lexington Ave N, Shoreview MN 55126-2917
  • Source
    USFDA