Events

867098 Philips Network Firewall (Cisco ASA 5506 Firewall) 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
    78849
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0850-2018
  • 사례 시작날짜
    2017-10-05
  • 사례 출판 날짜
    2018-03-03
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160720
  • 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
    Firewall installed with philips intellivue information center ix or information center classic may have a defective component, which may result in loss of connection to the information center ix. the defect involves the clock signal component within the firewall. this component has a high probability of failing in appliances that have been running for greater than 18 months. if the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. this failure will result in loss of communication between devices that are separated by the firewall, which may cause the information center to reboot.
  • 조치
    Philips sent an Urgent Recall Notice letter dated October 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a Philips representatives will contact affected customers to arrange for replacement of all affected units supplied by Philips. For questions contact your local Philips representative: Philips Customer Care Solution Center 800-722-9377.

Device

867098 Philips Network Firewall (Cisco ASA 5506 Firewall)
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers for use in U.S.A.: JMX2030Y2B8 JMX2030Y2CR JMX2030Y2BN JMX2030Y2AY JMX2040Y2NZ JMX2022Y1U4 JMX2040Y2NU JMX2045Y2L0 JMX2030Y2D9 JMX2030Y2B1 JMX2035Y0XC JMX2035Y0XT JMX2030Y2DY JMX2035Y0XA JMX2040Y2R2 JMX2031Y0EV JMX2039Y1FZ JMX2030Y2BT JMX2030Y2EE JMX2030Y2DM JMX194840WA JMX2014419Y JMX201441AB JMX201441A4 JMX2014Z155 JMX2014Z15C JMX2014Z15L JMX2039Y1H7 JMX2039Y1H5 JMX2039Y1HR JMX2039Y1JM JMX2022Y194 JMX2018Z009 JMX2022Y15F JMX2040Y2QP JMX2030Y2PZ JMX2045Y2E4 JMX20184033 JMX2030Y2A8 JMX2039Y1GB JMX2040Y2P9 JMX2030Y2E6 JMX2030Y2EG JMX2022Y181 JMX2022Y1A7 JMX2040Y2QW JMX2030Y2B6
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide
  • 제품 설명
    Philips Network Firewall (Cisco ASA 5506), Model # 867098
  • 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