Events

Device Recall CUSA NXT Ultra Surgical Aspirator System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra LifeSciences Corp. 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
    56463
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2638-2010
  • 사례 시작날짜
    2010-07-29
  • 사례 출판 날짜
    2010-09-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93734
  • 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
    Instrument, ultrasonic surgical - Product Code LFL
  • 원인
    A ground fault malfunction at the rectifier retaining screw may cause the aspiration pump in the cusa nxt service module to run at maximum speed, and continue to run until the entire system is turned off. this may result in excess aspiration that requires medical intervention.
  • 조치
    Integra issued Urgent: Product Recall Notification letters dated July 29, 2010 to all customers on July 29, 2010 identifying the affected products, issue prompting the recall, and actions to be taken by the customer. Letters were also forwarded to all Integra Account Reps. Customers were advised to discontinue use of and quarantine the affected service modules. The Surgical Aspirator may be operated without the Service Module, utilizing the hospitals wall aspiration. Company representatives will contact customers to arrange product return and repair of the affected service modules. Customers are to complete and return an enclosed Recall Acknowledgement and Return Form. The firm can be contacted at 609 936-2485.

Device

Device Recall CUSA NXT Ultra Surgical Aspirator System
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: NXT1022, NXT1023, NXT1026, NXT1043, NXT1050, NXT1051, NXT1056, NXT1057, NXT1008, NXT1018, NXT1019, NXT1029, NXT1030, NXT1042, NXT1062, NXT1063, NXT1064, NXT1067, NXT1069, NXT1070, NBC1001901IE.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA , including the states of AZ, CA, CO, FL, GA, IA, KY, MN, MO, NV, NY, OH, OR, RI, TX, VA, WI, and the countries of Germany, Hungary, Indonesia, Italy, Netherlands, and Switzerland.
  • 제품 설명
    Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System || CUSANXT2: Latex Free, Rx only. || Integra LifeSciences (Ireland) Limited || County Offaly, Ireland || Distributed by Integra Lifesciences Corporation || 311 Enterprise Drive || Plainsboro, NJ 08536.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.