Events

Device Recall McKesson Cardiology ECG Management 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 McKesson Israel Ltd. 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
    70144
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0910-2015
  • 사례 시작날짜
    2014-12-19
  • 사례 출판 날짜
    2015-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132318
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • 원인
    An ecg procedure time stamp is incorrect, due to a software error in the mckesson cardiology ecg management with software versions 13.1 and 13.1.1.
  • 조치
    McKesson sent an Urgent Field Safety Notice dated December 16, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed how to identify the potentially affected procedures and update the procedure date (if relevant) until a software update is made advailable for installation by McKesson. McKesson will proactively identify prior procedures affected by this issue and will notify customers of any issues identified. In addition to the Field Safety Notice, McKesson Israel will provide correction to the affected SW versions and will contact customers for deployment of a software patch that prevents this scenario from occurring. Customers with questions should contact McKesson Support at 1-866-777-0202. For questions regarding this recall call 404-338-3556.

Device

Device Recall McKesson Cardiology ECG Management
  • 모델명 / 제조번호(시리얼번호)
    MC13.1 and MC13.1.1
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
  • 제품 설명
    McKesson Cardiology ECG Management || It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
  • Manufacturer
    McKesson Israel Ltd.

Manufacturer

McKesson Israel Ltd.
  • 제조사 주소
    McKesson Israel Ltd., 4 Nehoshet St., or Towers, Bldg. B, Tel Aviv Israel
  • Source
    USFDA