Events

Device Recall Bravo Multimodality system 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health NeuroCare Division 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
    48758
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2389-2008
  • 사례 시작날짜
    2008-06-05
  • 사례 출판 날짜
    2008-09-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72066
  • 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 - Product Code GWQ
  • 원인
    Cardinal health neurocare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the nicled photic strobe option, part number 698-625500, with nicoletone eeg system. the photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the nicled photic. this reduced intensi.
  • 조치
    A "Cardinal Health Urgent: Medical Device Correction" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card. If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email shane.sawall@cardinalhealth.com.

Device

Device Recall Bravo Multimodality system
  • 모델명 / 제조번호(시리얼번호)
    085-463700
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia
  • 제품 설명
    NicoletOne photic adapter cable 085-463700
  • Manufacturer
    Cardinal Health NeuroCare Division

Manufacturer

Cardinal Health NeuroCare Division
  • 제조사 주소
    Cardinal Health NeuroCare Division, 5225 Verona Rd, Madison WI 53711-4497
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA