Events

Pentax Video Esophagoscopes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pentax Medical Company 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
    60788
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0819-2012
  • 사례 출판 날짜
    2012-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106476
  • 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
    Esophagoscope (flexible or rigid) - Product Code EOX
  • 원인
    The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
  • 조치
    Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.

Device

Pentax Video Esophagoscopes
  • 모델명 / 제조번호(시리얼번호)
    EE-1580K A110273
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    EE- Series Video Esophagoscopes, EE-1580K. || Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • 제조사 주소
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • 제조사 모회사 (2017)
    HOYA Corp.
  • Source
    USFDA