Events

Device Recall IntelePACS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intelerad 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
    68719
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2267-2014
  • 사례 시작날짜
    2014-07-03
  • 사례 출판 날짜
    2014-08-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128558
  • 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
    In specific situation a partially truncated file may be written to the intelepacs server. this partially truncated file still can be viewed by inteleviewer and inteleviewer will report to the user that the file in question is complete. this situation only occurs if a file is partially truncated.
  • 조치
    Intelerad sent an Urgent Recall for Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that a new software release will be installed on the system. Afterwards, an audit will be run on the the entire PACS to identify all image data that may have been truncated. Customers were requested to complete and return the attached Client Response Form.

Device

Device Recall IntelePACS
  • 모델명 / 제조번호(시리얼번호)
    software versions 3-8-1 to 4-9-1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
  • 제품 설명
    IntelePACS software versions 3-8-1 to 4-9-1, || Product Usage: || IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
  • Manufacturer
    Intelerad Medical Systems

Manufacturer

Intelerad Medical Systems