Events

IntelliVue MX40 Patient Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Electronics North America 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
    75209
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0291-2017
  • 사례 시작날짜
    2016-09-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149668
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Philips intellivue mx40 patient wearable monitor configuration setting disables generation and delivery of ecg alarms to piic ix.
  • 조치
    The firm, Philips Healthcare, sent a "Field Safety Notice (FSN)" dated 9/14/2016 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to make sure that the MX40 Patient Wearable Monitor local configuration setting 'Alarms On' is configured to its factory default until your software is upgraded; and follow the instructions listed in the letter. A Philips Healthcare representative will contact customers with affected devices to arrange for the installation of the software upgrade. If you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.

Device

IntelliVue MX40 Patient Monitor
  • 모델명 / 제조번호(시리얼번호)
    SW Revisions: B.05.28, B.05.29, and B.05.32
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • 제품 설명
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g || Product Number: 865352 || Exchange part: || 453564262491 || 453564262511 || 453564615311 || 453564615331 || 453564262571 || 453564262591 || Exchange part: || 453564262531 || 453564262551 || 453564262571 || 453564262591 || 453564615351 || 453564615371 || 453564467761 (Korea) || 453564467781 (Korea) || 453564451791 (Japan, Taiwan, Indonesia) || 453564451811 (Japan, Taiwan, Indonesia) || 453564467821 (Mexico) || 453564467841 (China) || 453564467861 (China) || Worldwide || SW Revisions: B.05.28, B.05.29, and B.05.32 || Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA