Hologic Fluoroscan Mini CArm Model with InSight2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hologic, 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
    63180
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2452-2012
  • 사례 시작날짜
    2012-09-14
  • 사례 출판 날짜
    2012-09-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    Insight2, version 4.0 and 4.0.1 - dicom images stored in pacs may be flipped 180¿around vertical axis. insight fd, version 5.0.1 and 5.0.2 - dicom images stored in pacs may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.
  • 조치
    Hologic issued an Urgent: Medical Device recall letter dated September 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Halogen corrected the anomaly and they provided the customer with the revised version of the software. Customers were asked to update their systems in accordance with the instructions provided with the software included with the letter. Customers were also asked to complete the attached acknowledgement form and fax or mail it to the firm at their earliest convenience. For any questions customers were instructed to call Hologic's Help Desk at 1-800-321-4659. For questions regarding this recall call 781-999-7300.

Device

  • 모델명 / 제조번호(시리얼번호)
    Software version 4.0 and 4.0.1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia,Belgium, Canada, China, Germany, Ecuador, Spain, France, Great Britain, Greece, Hong Kong, Italy, Japan Korea, Lithuvania, Neherlands, qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan, South Africa, and Switzerland.
  • 제품 설명
    Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 || The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hologic, Inc., 35 Crosby Dr, Bedford MA 01730-1450
  • 제조사 모회사 (2017)
  • Source
    USFDA