Device Recall Philips Avalon Fetal Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare 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
    53889
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0552-2010
  • 사례 시작날짜
    2009-11-23
  • 사례 출판 날짜
    2009-12-17
  • 사례 상황
    Completed
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    System, Monitoring, Perinatal - Product Code HGM
  • 원인
    Potential for inaccurate ultra-sound derived fetal heart rate readings in philips avalon fetal monitors. although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous generation philips series 50 fetal monitors. clinical decisions bas.
  • 조치
    Philips notified customers with an Urgent Medical Device Recall notice and Instructions for Use Addendum on 11/23/09 via UPS. Philips is providing the Addendum to reinforce the Avalon Instructions for Use regarding: " Recognizing these phenomena as they relate to the Avalon Fetal monitor and fetal monitors in general; and " Understanding the differences between the Philips Avalon Fetal Monitors and their predecessors, the Philips Series 50 Fetal Monitors, as they relate to the display of ultrasound-derived FHR. Philips is providing access to application specialists who are on call 24 hours a day to assist users with questions related to device use by calling 1-800-722-9377, press <3> then <1> for patient monitoring application issues and ask to speak with an application specialist. Customers will be requested to incorporate the information contained in the Urgent Medical Device Recall notice and the Addendum to the Instructions for Use with the existing Avalon labeling (Instructions for Use) provided with the product. Customers will be asked to complete an enclosed Confirmation Form indicating that they have received and disseminated this information, and then return the completed form to Philips. Questions about this field action or reports of product problems should be directed to the Philips Response Center at 1-800-722-9377.

Device

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (US and Puerto Rico). Foreign: Afghanistan Algeria Argentina Australia Austria Bahrain Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Estonia Finland France French Guiana Gabon Germany Greece Guadeloupe Guatemala Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macau Malaysia Martinique Mauritius Mexico Moldova Morocco Namibia Netherlands Netherlands Antilles New Caledonia New Zealand Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Turks and Caicos Islands Ukraine United Arab Emirates United Kingdom Uzbekistan Venezuela Viet Nam Zambia
  • 제품 설명
    Philips Avalon Fetal Monitor FM 50 || Catalog Number: M2705A.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
  • Source
    USFDA