Events

Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology, 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
    58884
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2664-2011
  • 사례 시작날짜
    2011-05-23
  • 사례 출판 날짜
    2011-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100470
  • 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
    Catheter, electrode recording, or probe, electrode recording - Product Code DRF
  • 원인
    The recall was initiated because biosense webster, inc. has recently become aware that 20 electrodes catheters with auto id technology are not being recognized when connected to the carto 3 system.
  • 조치
    Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.

Device

Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,
  • 모델명 / 제조번호(시리얼번호)
    Catalog # D7R20P14CT
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
  • 제품 설명
    ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # || D7R20P14CT || The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
  • 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