Events

Nicolet Cortical Stimulator Control Unit, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CareFusion 209 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
    60223
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0800-2012
  • 사례 시작날짜
    2011-10-05
  • 사례 출판 날짜
    2012-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104816
  • 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
    Electrode, cortical - Product Code GYC
  • 원인
    Carefusion is recalling the nicoletone software v5.60.2-5.71.4 used with the cortical stimulator control unit. it is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. also, it has been determined that the stimulus cable connection in the cortical s.
  • 조치
    CareFusion sent an "Urgent: Field Safety Corrective Action Notification" letter dated October 5, 2011 to all affected consignees. The letter described the product, the problem and urgent actions to be taken. Consignees were advised to immediately provide their customers with the attached customer notification letter. Consignees were instructed to complete and return the Verification Form enclosed in the notice. For questions on this matter call 1-800-356-0007 ext. 5129.

Device

Nicolet Cortical Stimulator Control Unit,
  • 모델명 / 제조번호(시리얼번호)
    CS09350168 CS09350168 CS-09140115 CS-09140135 CS-09140114 CS09160139 CS-09160155 CS-09070102R CS-09350179 CS-09350177 CS-09160147 CS-09160113 CS09140119 CS0916148 CS09350165 CS09140132 CS-09140122 Unknown Unknown CS-09350173 CS-09160136 CS-09160153 CS09350181 CS09350183 CS-09070109 RA090266M CS-09350171 C64SSU100081-0 CS-09350172 CS09140128 CS-09350174 CS-09350170 CS-09140111 Unknown CS-09160152 Unknown Unknown CS-09160141 CS-09160144 Unknown Unknown CS-09140117 CS09140112 CS-09160158 CS-09160123 CS-09160137 CS-09160126 CS-09140127 CS09350164 CS09140125
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AR, CA, FL, GA, HI, KY, MI, MO, NY, TX and WA and the countries of: CANADA, CHILE, CHINA, COATIA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, KOREA, NORWAY, PORTUGAL, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, RUSSIA and UNITED KINGDOM.
  • 제품 설명
    Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 || Product Usage: || The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
  • Manufacturer
    CareFusion 209 Inc.

Manufacturer

CareFusion 209 Inc.
  • 제조사 주소
    CareFusion 209 Inc., 1850 Deming Way, Middleton WI 53562-3530
  • Source
    USFDA