Events

Device Recall Merge PACS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Merge 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
    74651
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2303-2016
  • 사례 시작날짜
    2016-01-30
  • 사례 출판 날짜
    2016-07-29
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148106
  • 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
    A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
  • 조치
    The recalling firm, Merge, issued an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/27/2016 via e-mail on 1/30/2016 or via certified mail if they did not have an e-mail address for the customers. The letter described the product, problem and actions to be taken. The customers were instructed to not discontinue use of Merge PACS; to open prior comparison studies in the secondary viewer to check if there were annotations and read the report or visit note pertaining to that study to see if there are noted findings that were not otherwise apparent; to receive an upgrade call Merge Customer Service at (877) 741-5369 or send an email to support@merge.com to schedule the upgrade (Reference this call #2016-010); complete the online form: http://www.merge.com/Landing-Pages/Customer-Upgrade-Decline-Form.aspx no later than 2/22/2016; If you decide to decline the maintenance release, complete the attached Customer Decline Response form and return to Merge Healthcare via recall@merge.com, and ensure all users of the product are provided with this notification. If you have further distributed this product, identify your customers and notify them at once of this product recall. If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.

Device

Device Recall Merge PACS
  • 모델명 / 제조번호(시리얼번호)
    Versions: V6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6.0, 6.6.1, 6.6.1.1, 6.6.2
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
  • 제품 설명
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. || Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.