Events

Device Recall AxSYM System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories, 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
    25055
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0421-03
  • 사례 시작날짜
    2002-12-18
  • 사례 출판 날짜
    2003-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-04-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25086
  • 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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • 원인
    Gas springs supporting processing center cover lose pressure after repeated usage causing the cover to unexpectedly close.
  • 조치
    Abbott Laboratories sent a December 18, 2002 letter to all consignees informing consignees of their plans to install a locking mechanism on all AxSYM Systems. The installations will be performed by Abbott Representatives. A customer reply form was included in the device correction letter.

Device

Device Recall AxSYM System
  • 모델명 / 제조번호(시리얼번호)
    List Numbers: 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Dominican Republic, El Salvador, Canada, Germany, Ireland, England, Belgium, France, Austria, Italy, Spain, Russia, Japan, Singapore, Hong Kong, Taiwan, Thailand, Malaysia, Korea, Australia, New Zeland, Honduras, Costa Rica, Trinidad, Bahamas, Northern Antilles, Bermuda, Panama, West Indies, Paraguay, Norway, Kingstow, VC
  • 제품 설명
    AxSYM System, Lift Mechanisms: List Numbers 7A83-01, 7A83-95, 7A83-98, and 7A83-03
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • 제조사 주소
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 2020, Irving TX 75038
  • Source
    USFDA