Events

THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    55695
  • 사례 위험등급
    II
  • 사례 시작날짜
    2017-09-13
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Biosense webster has received an increased number of complaints related to the display of alert 402 on the carto 3 system for certain lots of thermocool brand catheters. alert 402 implies magnetic distortion which may result in inaccurate catheter tip location information. this may lead the physician to ablate in an unintended area when delivering rf energy. the user manual provides steps for resolving this alert but for the lots subject to this recall those steps are not effective. subject lots are therefore being removed.

Device

THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: D134703 (Lot serial: 17685897L); Model Catalog: D134805 (Lot serial: 17680149L); Model Catalog: D134804 (Lot serial: 17685816L); Model Catalog: D134805 (Lot serial: 17685816L); Model Catalog: D134804 (Lot serial: 17689537L); Model Catalog: D134805 (Lot serial: 17689537L); Model Catalog: D134804 (Lot serial: 17692186L); Model Catalog: D134805 (Lot serial: 17692186L); Model Catalog: D134804 (Lot serial: 17692191L); Model Catalog: D134805 (Lot serial: 17692191L); Model Catalog: D134701 (Lot serial: 17682851L); Model Catalog: D134702 (Lot serial: 17682851L); Model Catalog: D134703 (Lot serial: 17682851L); Model Catalog: D134701 (Lot serial: 17689463L); Model Catalog: D134702 (Lot serial: 17689463L); Model Catalog: D134703 (Lot serial: 17689463L); Model Catalog: D134701 (Lot serial: 17685811L); Model Catalog: D134702 (Lot serial: 17685811L); Model Catalog: D134703 (Lot serial: 17685811L); Model Catalog: D134701 (Lot serial: 17685897L); Model Catalog: D134702 (Lot serial: 17685897L); Model Catalog:
  • 제품 설명
    THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER;THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.