Events

Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-2014-RN-00632-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00632-1
  • 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
    Ge healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity. if a device is improperly re-installed, the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a servicemaintenance activity, but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.
  • 조치
    GE is advising customers that if they observe any abnormal collimator movement, immediately stop using the system and contact their local GE Healthcare Service Representative. During planned maintenance, customers are also advised not to perform the demounting and re-mounting of collimator for Proteus XR/a and Revolution XR/d X-ray imaging systems as stated in the manuals. A GE Healthcare service representative will contact customers to verify that all affected systems are properly installed and to implement correction if necessary.

Device

Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systems
  • 모델명 / 제조번호(시리얼번호)
    Proteus XR/a X-ray imaging systems and Revolution XR/d X-ray imaging systemsProteus XR/a X-ray imaging systems installed with collimator part numbers 2261763 and 2261765 ARTG 98099 All Revolution XR/d X-ray imaging systemsARTG 114083
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd