Events

Device Recall Spacelabs ARKON Anesthesia Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Del Mar Reynolds Medical, 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
    65630
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1771-2013
  • 사례 시작날짜
    2013-06-07
  • 사례 출판 날짜
    2013-07-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119781
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • 원인
    Spacelabs arkon anesthesia system is recalled due to software defect. the system status computer may incorrectly determine that a communication error has occurred. if this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the system status computer screen that alerts the user of this error.
  • 조치
    Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. For questions regarding this recall call 800-522-7025.

Device

Device Recall Spacelabs ARKON Anesthesia Workstation
  • 모델명 / 제조번호(시리얼번호)
    ARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
  • 제품 설명
    Spacelabs ARKON Anesthesia Workstation. || Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • 제조사 주소
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA