Events

Device Recall BMSI MicroJack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Nicolet Biomedical Div of Viasys Healthcare 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
    38424
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1225-2007
  • 사례 시작날짜
    2007-07-17
  • 사례 출판 날짜
    2007-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53645
  • 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
    Electroencephalograph System - Product Code GWQ
  • 원인
    The bmsi "microjack" patient interface electrode connection device used with the eeg monitor systems was found to be mis-wired. a complainant alleged that during depth electrode eeg study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.
  • 조치
    VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters "Viasys HealthCare Urgent Medical Device Field Correction (Recall)" were sent 7/17/07 to both domestic and international customers.

Device

Device Recall BMSI MicroJack
  • 모델명 / 제조번호(시리얼번호)
    Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, ISRAEL, LITHUANIA, RUSSIA, FRANCE, IRELAND, UNITED KINGDOM , SPAIN, YEMEN, JAPAN, TAIWAN, KOREA, CHINA, SAUDI ARABIA, HONG KONG, INDIA, COLOMBIA, BRAZIL, GERMANY, CANADA, DENMARK, ITALY, MEXICO, and THAILAND.
  • 제품 설명
    BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.
  • Manufacturer
    Nicolet Biomedical Div of Viasys Healthcare

Manufacturer

Nicolet Biomedical Div of Viasys Healthcare
  • 제조사 주소
    Nicolet Biomedical Div of Viasys Healthcare, 5225 Verona Rd, Madison WI 53711-4497
  • Source
    USFDA