Events

Device Recall Artis zeego 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    80286
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2314-2018
  • 사례 시작날짜
    2018-05-01
  • 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=165059
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    After the large display returns from power save mode, it may not show an image, and stay black without showing an error message although x-ray is still possible. the problem does not occur during an ongoing procedure. if the problem occurs, the system cannot be operated normally. it may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
  • 조치
    On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed. The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.

Device

Device Recall Artis zeego
  • 모델명 / 제조번호(시리얼번호)
    160851 160869 160943 160817 160852 160834 160972 160463 160944 160406 160913 160877 160488 160800 160884 160823 160916 160814 160872 160905 160915 160447 160481 160501 160874 160862 160860 160878 160957 160412 160856 160387 160432 160903 160917 160889 160813 160461 160912 160919 160838 160507 160487 160825 160850 160430 160801 160323 160498 160509 161004 160896 160894 160830 160519 160469
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Artis zeego, Material no. 10280959 || , for angiography and whole body radiographic/fluoroscopic procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA