Events

Device Recall Zoll E Series Defibrillator with 12 Lead ECG 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
    46408
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1167-2008
  • 사례 시작날짜
    2008-01-15
  • 사례 출판 날짜
    2008-06-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67385
  • 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 defibrillator - Product Code MKJ
  • 원인
    Incorrect patient records: patient records that have been stored, then later transmitted or printed may not be the correct record. records that are transmitted or printed immediately following acquisition are correct.
  • 조치
    Consignees were notified by an Urgent Device Correction letter sent on 1/14/08. The letter instructed users to complete and return a response form. Upon receipt of the response form, the recalling firm will have sent a software update. The letter also provided instructions for users to follow in order to avoid the software error before the software update was received. For additional information, contact 1-800-348-9011.

Device

Device Recall Zoll E Series Defibrillator with 12 Lead ECG
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA and countries of Canada, AE, Australia, Belgium, Chile, Germany, Spain, France, UK, Hungary, India, Italy, Jordan, Kuwait, Netherlands, Russia, Saudi Arabia, Singapore and ZA.
  • 제품 설명
    Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher; Zoll Medical Corporation, Chelmsford, MA 01824.
  • 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 01824-4105
  • 제조사 모회사 (2017)
    Asahi Kasei Corp.
  • Source
    USFDA