Events

Device Recall RadSuite 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
    74924
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2685-2016
  • 사례 시작날짜
    2016-01-30
  • 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=148881
  • 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
    Interventional radiology (ir) images are stored as jpeg2k lossless in merge enterprise archive (ea) and are not displaying correctly in radsuite.
  • 조치
    The firm, Merge, sent an "URGENT: MEDICAL DEVICE RECALL" letters dated 1/29/2016 and 5/25/2016 via e-mail or via certified mail if they did not have an e-mail address for the customers. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: you must discontinue using the affected version of RadSuite or iConnect Enterprise Archive with GE AW Workstation; use the workaround listed in the letter; complete and return the enclosed form no later than June 17, 2016; ensure that all users of the product are provided with the notification; if you have further distributed this product, please identify your customers and notify them at once of this product recall Merge has a released fix available for this issue. If you have any additional questions, please send an email to recall@merge.com or call 800-724-5970 ext 8027.

Device

Device Recall RadSuite
  • 모델명 / 제조번호(시리얼번호)
    Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to: CO and OK.
  • 제품 설명
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. || RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.