Events

NANOKNIFE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics, 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
    59825
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3258-2011
  • 사례 시작날짜
    2011-04-04
  • 사례 출판 날짜
    2011-09-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103817
  • 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
    Low energy direct current thermal ablation system - Product Code OAB
  • 원인
    Some units of nanoknife have the potential to deliver a shortened pulse width without indicating an error. the affected units contain a "gome" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.
  • 조치
    AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.

Device

NANOKNIFE
  • 모델명 / 제조번호(시리얼번호)
    Batch/Serial Numbers: 00120508, 00090508, 00880909, 00371008, 00670709, 00850909, 00890909, 00780709, 00220708, 00300708, 00951009, 00900909, 00800709, 00260708, 00650709, 00690709, 00920909, 00930909, 00770709, 00130508, 01001009.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,
  • 제품 설명
    ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 || Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • 제조사 주소
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA