Events

First Save G3 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiac Science 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
    50064
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0917-2009
  • 사례 시작날짜
    2008-10-13
  • 사례 출판 날짜
    2009-02-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74606
  • 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
    Potential for aed to not deliver defibrillation therapy.
  • 조치
    On October 13, 2008 Cardiac Science began sending via Fed-Ex letters and software upgrade kits. Mailing of letters and software upgrade kits is anticipated to be completed by November 21, 2008. The letter instructs consignees to install the software update, assure that the AED information test file generated by the update software is returned to the firm, and complete the postage paid response card and return it to the firm. If the affected devices are no longer in the possession of the consignee, the consignee is to contact the firm and forward the update kit and letter to the person who has the AED in their possession. A separate letter is being sent to distributors. The letter advised to install the software upgrades for any units in stock or to forward the software upgrade along with the end user letter enclosed and that the AED information text file generated by the update software must be returned to the firm. The firm will visit the locations of individual national account customers and install the update. OEM partners will be notified and provided the information and update kits to provide to their customers.

Device

First Save G3
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 332321 and 334948.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA, Puerto Rico, Virgin Islands, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechoslovakia, Denmark, Dominican Republic, France, Germany, Greece, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Kuwait, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, UK, and Ukraine.
  • 제품 설명
    Cardiac Science First Save Automated External Defibrillator G3 9300C
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation
  • 제조사 주소
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • 제조사 모회사 (2017)
    Cardiac Science Corporation
  • Source
    USFDA