Events

Device Recall Philips Healthcare PCR Eleva Radiological Image Processing System 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
    59473
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3205-2011
  • 사례 시작날짜
    2011-07-27
  • 사례 출판 날짜
    2011-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102849
  • 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 Radiography Image Processing System - Product Code LLZ
  • 원인
    The mirror icon on the bottom of each image could be interpreted as a right marker for side indication if the image is mirrored again within a pacs system. this could potentially lead to a misdiagnosis.
  • 조치
    Philips Healthcare Inc. sent out "Urgent --Medical Device Correction" notices dated June 10, 2011 to all affected customers. The letter described the product and problem. Customers were informed the "burned-in Mirror-Icon" may be misinterpreted as a Right marker. Customers are advised to preferably use lead markers during each X-ray acquisition or alternatively electronic annotations on each image for side indication. The presentation of these markers within each image will clearly show the difference between the intended Left/Right indication and the little mirror ICON. Philips will install improved software that prevents the misinterpretation of the symbol and will schedule the installation of the updated software. For questions on this recall call Phillips Healthcare Inc. at 978-687-1501.

Device

Device Recall Philips Healthcare PCR Eleva Radiological Image Processing System
  • 모델명 / 제조번호(시리얼번호)
    Software version 1.2 Models: 732040, 732042, 732044, 732048, 732050, 732052, 732080, 732082
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide distribution; and including the countries of Albania, Angola, Argentina, Australia, Austria, Azerbaijan, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Croatia, Denmark, Egypt, France, Germany, Ghana, Greece, Greece, Haiti, Hungary, Indonesia, Iraq, Israel, Italy, Kazakhstan, Kenya, Latvia, Libya, Liechtenstein, Lithuania, Malawi, Malta, Martinique, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Philippines, Portugal, Puerto Rico, Romania, Russia, Saudi-Arabia, Serbia, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Tanzania, Thailand, Tschech. Rep, Turkey, Turkmenistan, UAE, Uganda, and United Kingdom.
  • 제품 설명
    PCR Eleva Radiological Image Processing System with software R.1.2 || Philips Healthcare, Inc. || A computed radiography image processing system.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

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