Events

Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ZOLL Medical Corporation 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
    67749
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1311-2014
  • 사례 시작날짜
    2014-03-05
  • 사례 출판 날짜
    2014-03-31
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126205
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • 원인
    Defibrillator/pacemaker/monitor may latch in a continuous device reset loop and cannot be used.
  • 조치
    Zoll Medical issued a Notification letter daetd March 5, 2014, to all affected consignees. The notification letter provides information on how to avoid the issue and instructs customers to contact ZOLL to get affected devices updated. Customers will be given the option to have a software upgrade kit sent to them to update their devices or return devices to ZOLL Service department in Chelmsford Massachusetts to have the device upgraded with the latest software release (Software version 02.16.04.00). Customers with questions were instructed to contact the 24/7 technical support numbers 1 (800) 348 9011 or +1 (978) 421 9460 to assist users with any aspect of this notice.

Device

Device Recall Zoll Medical X Series/PropaqMD/PropaqM Defibrillator/Pacemaker/Monitor
  • 모델명 / 제조번호(시리얼번호)
    System Software Version 02.10.02.00 or Higher
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, Afganistian, Australia, Belgium, Czech Republic , China, Chile, Croatia, Denmark, France, Great Britain, Hungary, Israel, Italy, Japan, Korea, Kuwait, Russia, Saudi Arabia, Singapore, South Africa,Thailand, and Turkey.
  • 제품 설명
    Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
  • Manufacturer
    ZOLL Medical Corporation

Manufacturer

ZOLL Medical Corporation
  • 제조사 주소
    ZOLL Medical Corporation, 269 Mill Road, Chelmsford MA 01824
  • 제조사 모회사 (2017)
    Asahi Kasei Corp.
  • Source
    USFDA