Events

AIRO Mobile CT ScannerModel Number: 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-00924-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00924-1
  • 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
    Mobius imaging has identified an issue with the configuration settings of the main-drive motion controller on specific airo mobile ct scanners. if a main-drive motor has a broken encoder or sensor wire there is a risk of unintended motion while driving or transporting the airo system. the routing of the main-drive motor cable can cause long-term repeated bending & flexing of the cable and possible breakage of the motor wire(s) while the system goes into / out of transport mode and while driving or transporting the system. if a wire were to break, the main-drive motor would not get the correct feedback and the motor could behave unpredictably.
  • 조치
    Review the supplied information and attach the warning label provided to the machine as per the instructions in the Customer Letter.

Device

AIRO Mobile CT ScannerModel Number: MobiCT-32
  • 모델명 / 제조번호(시리얼번호)
    AIRO Mobile CT ScannerModel Number: MobiCT-32Catalogue Number: 2017-FSCA-001Serial Numbers: AIRO-0162, AIRO-0143, AIRO-0154, AIRO-0146 and AIRO-0149ARTG Number: 223542
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd