Events

Device Recall The LIFEPAK 15 monitor/defibrillator 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
    75743
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0761-2017
  • 사례 시작날짜
    2010-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151125
  • 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
    Customer complaint was received relating to a lifepak15 device that would power on then power down unexpectedly after a short period of use. when the lp15 powered down, power could be immediately restored by activation of the power button. the device was connected to a cellular modem from multitech systems for use with life net services. the corrective action was completed by velocitor solutions in december 2010.
  • 조치
    Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.

Device

Device Recall The LIFEPAK 15 monitor/defibrillator
  • 모델명 / 제조번호(시리얼번호)
    This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    worldwide
  • 제품 설명
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical || personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
  • 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