Events

INFINITI PLUS DISPOSABLE NEEDLE GUIDE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO 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
    90154
  • 사례 위험등급
    II
  • 사례 시작날짜
    2018-02-16
  • 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
    Civco has recently discovered a quality issue with infiniti bracket. the affected brackets were included in the kits identified and manufactured between 11/2009 through 12/2017. description of problem: if the length of the mount may be longer than specified it can allow the needle guide insert to puncture the cover which is applied between the mount and needle guide assembly. this does not prevent the assembly from functioning as intended to keep the biopsy needle in the ultrasound scanning plane.

Device

INFINITI PLUS DISPOSABLE NEEDLE GUIDE
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 698-009 (Lot serial: M419650); Model Catalog: 698-009 (Lot serial: M427370); Model Catalog: 698-009 (Lot serial: M388690); Model Catalog: 698-009 (Lot serial: M220960)
  • 제품 설명
    INFINITI BRACKET (SOLD AS PART OF CIVCO BRAND BIOPSY STARTER KITS AND BIOPSY BRACKET)
  • Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO

Manufacturer

CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO