Events

Device Recall iSite PACS software versions 3.6.28.x and 4.1.x. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Healthcare Informatics, 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
    49403
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0118-2009
  • 사례 시작날짜
    2008-08-29
  • 사례 출판 날짜
    2008-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73260
  • 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
    Picture Archiving and Communication System - Product Code LLZ
  • 원인
    Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using conference presentation states and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when pixel spacing and imager pixel spacing dicom tag values are bot.
  • 조치
    A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.

Device

Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.
  • 모델명 / 제조번호(시리얼번호)
    Software versions 3.6.28.x and 4.1.x.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
  • 제품 설명
    iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. || The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
  • Manufacturer
    Philips Healthcare Informatics, Inc.

Manufacturer

Philips Healthcare Informatics, Inc.
  • 제조사 주소
    Philips Healthcare Informatics, Inc., 4100 E 3rd Ave Ste 101, Foster City CA 94404-4819
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA