Device Recall Sentry semi automatic external defibrillator (AED) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Defibtech, LLC 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
    56729
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0077-2011
  • 사례 시작날짜
    2010-08-27
  • 사례 출판 날짜
    2010-10-18
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Data cards may include an incorrect format which may cause the aed to not function correctly.
  • 조치
    Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service. If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation. For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.

Device

  • 모델명 / 제조번호(시리얼번호)
    Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    USA - Nationwide Distribution and Puerto Rico
  • 제품 설명
    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). || The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
  • Source
    USFDA