Events

Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ZOLL Medical Corporation, World Wide Headquarters 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
    55115
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1547-2010
  • 사례 시작날짜
    2010-03-24
  • 사례 출판 날짜
    2010-05-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89939
  • 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
    Device issued shock advised message but failed to auto-charge the defibrillator.
  • 조치
    Zoll Medical Corporation issued an "Urgent Medical Device Correction" notification dated March 26, 2010 via certified mail to consignees who have received affected product. Customers will be contacted and given the option to have a software upgrade kit to update their devices or return devices to the firm to have the device upgraded. For further information, contact Zoll Medical Corporation 24/7 Technical Support at 1-800-348-9011 or 1-978-421-9460.

Device

Device Recall ZOLL E Series Defibrillator/Pacemaker/Monitors
  • 모델명 / 제조번호(시리얼번호)
    Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom.
  • 제품 설명
    ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Zoll Medical Corporation, Chelmsford, MA. || Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
  • Manufacturer
    ZOLL Medical Corporation, World Wide Headquarters

Manufacturer

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