Events

Device Recall Brilliance CT Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems (Cleveland) 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
    38264
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0110-2008
  • 사례 시작날짜
    2007-05-25
  • 사례 출판 날짜
    2007-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53273
  • 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
    Computed tomography scanner - Product Code JAK
  • 원인
    Two potential artifacts may appear in some images from head scans on the brilliance 40/64 systems. these artifacts may lead to misdiagnosis.
  • 조치
    Firm notified its customers via a Product Safety Notification letter dated May 25, 2007, warning the user of a possible appearance of artifacts which could lead to a misdiagnosis and improper treatment.

Device

Device Recall Brilliance CT Systems
  • 모델명 / 제조번호(시리얼번호)
    Model No. 728231. Version 2.2.1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Argentina, Austria, Australia, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Denmark, Ecuador, Egypt, England, Equatorial Guinea, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Korea, Lebanon, Libya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Phillipines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, and West Indies.
  • 제품 설명
    Brilliance CT Systems, 40 slice configuration. Computed tomography scanner.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA