Artis Q systems with s/w version VD11 and Gigalix X-Ray tubes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare Pty Ltd 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
    RC-2016-RN-01475-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-10
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    For artis systems with software version vd11, and gigalix x-ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci “small” and “micro” (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.
  • 조치
    A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end. Users are advised that: - For system operation with a 2-foci Gigalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program. - For system operation with a 3-foci Gigalix X-Ray tube, fluoroscopy is still possible with the "small" or "micro" focus that is still intact through manual selection of a corresponding fluoro program. In addition, image acquisition with the large focus is still possible. - There should be standard emergency procedures in place in case of system failures.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis Q systems with s/w version VD11 and Gigalix X-Ray tubesARTG Number: 273952
  • Manufacturer

Manufacturer