Cios Alpha (Portable fluoroscopic x-ray system) 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-00270-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-10
  • 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
    Issues have been identified that may arise on the cios alpha unit:a) if the system language is set to english and the yyyymmdd date format is used, the patient’s date of birth received through the dicom worklist and query/retrieve will be displayed with month and day reversed for patients who have birthdays on days 1 through 12. birth dates for days 13 through 31 are displayed correctly. the issue only appears to happen for days 1 through 12.B) system crash may occur during dvd live recording if radiation is released while the dvd icon on the flc status bar is blinking. in this case error messages will be displayed and a system reset is necessary.C) sporadically the system will not be ready for radiation during reconnection of the trolley to the main unit. a system reboot is necessary.The issues may result in a delay in diagnosis or therapy while the system is rebooted.
  • 조치
    A modification of Cios Alpha is being developed by Siemens that will resolve the issues. The roll out is planned for end of 2016. In the interim, Siemens is providing users with work around instructions as follows: a) The user can prevent the issue by changing the date format to DDMMYYYY. This format will work properly for all dates. If this may not be practicable, the user should be aware that the day and month may get reversed. b) The user is advised not to release radiation as long as the DVD icon is blinking. c) Please do not disconnect and re-connect the trolley if the system is needed immediately. This action has been closed out on 14 June 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Cios Alpha (Portable fluoroscopic x-ray system)Catalogue Number: 10308191ARTG Number: 102180
  • Manufacturer

Manufacturer