Events

Mobius Imaging Airo Mobile CT System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mobius Imaging, LLC 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
    79159
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0715-2018
  • 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=161461
  • 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, tomography, computed - Product Code JAK
  • 원인
    If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the ct system is homing the axis at startup or preparing for a scan.
  • 조치
    Mobius sent an Urgent Field Safety Notice letter dated September 26, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Mobius Imaging is advising all customers to discontinue using the AIRO until update is completed on their system. Please provide a copy of this Field Safety Notification to all AIRO operators that use the AIRO system, and quarantine the system per hospital policies and procedures.

Device

Mobius Imaging Airo Mobile CT System
  • 모델명 / 제조번호(시리얼번호)
    Requested.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, NC, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Pakistan, Russia, Saudi Arabia, Spain, Switzerland, UAE, Uzebekistan
  • 제품 설명
    AIRO Mobile CT System, Model Number: MobiCT-32 || Product Usage: || The AIRO¿ is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
  • Manufacturer
    Mobius Imaging, LLC

Manufacturer

Mobius Imaging, LLC
  • 제조사 주소
    Mobius Imaging, LLC, 2 Shaker Rd Ste F100, Shirley MA 01464-2535
  • 제조사 모회사 (2017)
    Mobius Imaging LLC
  • Source
    USFDA