Events

Device Recall Biosense NaviStar RMT Catheters 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
    50784
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0368-2010
  • 사례 시작날짜
    2008-10-02
  • 사례 출판 날짜
    2009-11-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77277
  • 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
    radiofrequency ablation catheter, electrode recording catheter - Product Code LPB
  • 원인
    Biosense webster initiated the recall because of the potential concern with one of the printed circuit board (pcb) components used in the navistar rmt catheters, which may cause the ablation catheter icon to shift on the map viewer when rf energy is being applied. therefore the user, attempting a linear ablation in the location displayed on the carto rmt screen, may ultimately apply rf energy to u.
  • 조치
    The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy." If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement. Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.

Device

Device Recall Biosense NaviStar RMT Catheters
  • 모델명 / 제조번호(시리얼번호)
    All lot numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI
  • 제품 설명
    Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02
  • Manufacturer
    BioSense Webster, Inc.

Manufacturer

BioSense Webster, Inc.
  • 제조사 주소
    BioSense Webster, Inc., Circuito Interior Norte, #1820, Parque Industrial Salvarcar, Cd. Juarez, Chihuahua Mexico
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA