Events

Recall of Cios Alpha (Portable fluoroscopic x-ray system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00270-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00270-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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

Cios Alpha (Portable fluoroscopic x-ray system)
  • Model / Serial
    Cios Alpha (Portable fluoroscopic x-ray system)Catalogue Number: 10308191ARTG Number: 102180
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA