Events

Device Recall Pentax Medical Inc. 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
    68753
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2290-2014
  • 사례 시작날짜
    2014-07-17
  • 사례 출판 날짜
    2014-08-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128601
  • 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
    Endoscope and/or accessories - Product Code KOG
  • 원인
    The instructions for use for the pentax of-b130 and of-b194 gas/water valve ifu if not followed carefully may cause a potential risk to health.
  • 조치
    Pentax Medical sent an Urgent Medical Device Recall Field Safety Corrective Action letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the Instruction for Use are not followed carefully by the user there is a potential risk to health for the patient, such as a perforation. Customers are asked to complete the attached response form and fax to (201) 799-4063. Customers should see the attached revised Instructions for Use Z632 R09. If you have any questions regarding this action, please feel free to contact your Sales Representative at : 800-431-5880 ext 2064

Device

Device Recall Pentax Medical Inc.
  • 모델명 / 제조번호(시리얼번호)
    Model No. OF-B130 OF-B194, all units.
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
  • 제품 설명
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
  • 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