Events

IntelliSpace PACS 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
    66560
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0269-2014
  • 사례 시작날짜
    2013-10-14
  • 사례 출판 날짜
    2013-11-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122607
  • 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, image processing, radiological - Product Code LLZ
  • 원인
    Philips healthcare became aware of a software problem with the intellispace pacs system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. the missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
  • 조치
    Philips sent an Urgent Field Safety Notice dated October 14, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please review the following with all radiology technicians who use lntelliSpace BY CUSTOMER/USER PACS: " Assure you and your colleagues are aware of the problem. " Verify that all images sent for each study are present on the iVault before the images are purged from the modality. o Use the image count from the lower right corner of the thumbnails as seen in Enterprise only. Single images (such as CR, DX and MG) show no image count, so the user should count those thumbnails without image counts as one. Add all the numbers up to come up with the total number of viewable images, stored to lntelliSpace. " Compare number of images sent from the modality and those sent from other 3rd party source to image count in IntelliSpace PACS. " If the image count on the modality or 3 party source indicates there are more images to the study than are present on the iVault, the study should be resent from the modality and/or 3 party source. " Resending the studies will typically correct the problem but the technician should again verify the image count is correct. If you need any further information or support concerning this issue, please INFORMATION AND contact your Philips representative or contact Care at isitecare@philips.com. Please call (650) 293-2300 for further questions.

Device

IntelliSpace PACS
  • 모델명 / 제조번호(시리얼번호)
    All units of these IntelliSpace PACS.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and country: Canada.
  • 제품 설명
    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA || IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
  • 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