Events

Pentax 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pentax of America 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
    75306
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0636-2017
  • 사례 시작날짜
    2016-08-15
  • 사례 출판 날짜
    2016-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150012
  • 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
    Colonoscope and accessories, flexible/rigid - Product Code FDF
  • 원인
    Pentax is initiating the product correction of several model numbers of pentax's colonoscope that were shipped between the clearance date of april 2014 and september 2015 because they contain the operation and reprocessing ifu's that were in use prior to the 2014 clearances and therefore did not include the cleared operation ifu, the updated reprocessing ifu or the dedicated reprocessing adaptor (for applicable models).
  • 조치
    Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.

Device

Pentax
  • 모델명 / 제조번호(시리얼번호)
    Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide and Japan
  • 제품 설명
    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
  • Manufacturer
    Pentax of America Inc

Manufacturer

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