Events

Device Recall SMARTABLATE System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biosense Webster, 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
    77575
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0210-2018
  • 사례 시작날짜
    2017-06-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156581
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • 원인
    Generator may inadvertently deliver rf energy if the foot pedal is placed in close proximity and oriented toward the stereotaxis magnets.
  • 조치
    All new U.S. and OUS customers, who have purchased the SMARTABLATE" Generator system since the launch of the original field action in March 2015 to the time the IFU was updated in November 2015, will be notified. The previously distributed Field Safety Notification Letter for the SMARTABLATE" Generator (Part Numbers# M490006 and M490007) and customer Acknowledgement Form will be sent to these new customers. Instructions included review the Field Safety Notice carefully, provide the notice to appropriate personnel in facility, ensure the SMARTABLATE System Foot Pedal is not located within the Stereotaxis RMT Lab, complete and return the Acknowledgement Forms, and maintain awareness of the notice.

Device

Device Recall SMARTABLATE System
  • 모델명 / 제조번호(시리얼번호)
    Product Codes M490006, M490007
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
  • 제품 설명
    SMARTABLATE RF System Generator
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • 제조사 주소
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA