Events

Device Recall 9195371DS Lithrotripsy Probe LotLDS12516 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Northgate 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
    77367
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0073-2018
  • 사례 시작날짜
    2017-05-24
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155847
  • 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
    Lithotriptor, electro-hydraulic - Product Code FFK
  • 원인
    The inner and outer labels on the product contain incorrect reference number of 9-202-3751ds. according to northgate technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. could delay care.
  • 조치
    Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.

Device

Device Recall 9195371DS Lithrotripsy Probe LotLDS12516
  • 모델명 / 제조번호(시리얼번호)
    Model No. 9-195-371DS, Lot/Serial Number LDS12516
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the following states : MA, NE and TN and Internationally to Canada.
  • 제품 설명
    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
  • Manufacturer
    Northgate Technologies, Inc.

Manufacturer

Northgate Technologies, Inc.
  • 제조사 주소
    Northgate Technologies, Inc., 1591 Scottsdale Ct, Elgin IL 60123-9361
  • 제조사 모회사 (2017)
    Trudell Medical Limited
  • Source
    USFDA