AIRO Mobile CT Scanner Model: MobiCT-32 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Brainlab Australia 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-2017-RN-01256-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-09-29
  • 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
    The manufacturer, mobius imaging, believes that due to an issue with the configuration settings of the tilt-drive motion controller, if a tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended tilt motion of gantry while airo system is homing the axis at startup or preparing for a scan. since the airo is not currently monitoring for intermittent connections or broken tilt-drive motor wires, if a wire breaks or the signal becomes intermittent the tilt-drive motor would not get the correct feedback and the motor could behave unpredictably. the following behaviours could be seen in the airo: when pushing the green button to home/tilt the gantry, the gantry may tilt in either direction, and at a higher than normal speed. the operator may not be able to respond (by releasing green button or pressing the emergency stop button) in time to prevent harm. to date, there have been no injuries reported related to this issue.
  • 조치
    Due to the risk of unintended (tilting) motion of the gantry, customers are advised to discontinue using the AIRO until the tilt drive motion firmware has been updated on their system. Brainlab is arranging the firmware update for installation on the affected serial numbers on 29 September 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    AIRO Mobile CT Scanner Model: MobiCT-32Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146, AIRO-0149, AIRO-0209 and AIRO-0217 ARTG Number: 223542
  • 의료기기 분류등급
  • Manufacturer

Manufacturer