Events

Device Recall The LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Physio Control, Inc. 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
    64427
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1082-2013
  • 사례 시작날짜
    2013-02-08
  • 사례 출판 날짜
    2013-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116122
  • 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
    Lifepak cr plus or lifepak express automated external defibrillators (aeds) are recalled due to the potential to experience an early internal battery depletion issue.
  • 조치
    The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device. Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.

Device

Device Recall The LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. || Automated external defibrillators.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • 제조사 주소
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA