Events

Philips Diagnostic Ultrasound System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems 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
    49065
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0522-2009
  • 사례 시작날짜
    2008-08-12
  • 사례 출판 날짜
    2008-12-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72768
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • 원인
    The system has a software defect that affects the display of estimated fetal weight (efw) growth percentile result values.
  • 조치
    On 8/12/08, the firm sent an Urgent - Medical Device Correction letter, dated July 2008, to all affected customers via UPS. The letter describes the reason for the recall, informs them that Philips Ultrasound is correcting the error, states that the software is under development, will be available in September 2008 and will contact the customer to upgrade their system. "In the interim, Philips recommends that you only use the Hadlock or Osaka growth tables to perform your EFW Growth Percentile calculations. You should make the appropriate selections in the Analysis Setup menu on your system."

Device

Philips Diagnostic Ultrasound System
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bosnia, Brazil, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Dominican Rep, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jordan, Kuwait, Malaysia, Martinique, Mexico, Moldova, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Rep, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Utd Arab Emirr., Venezuela, Viet Nam, Canada, Afghanistan, Albania, Argentina, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Italy, Japan, Korea Rep, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, SLOVAKIA, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, Uzbekistan, Venezuela, and Virgin Isl (Br).
  • 제품 설명
    Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. || Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 주소
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA