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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00270-1
Product Name/Description Cios Alpha
(Portable fluoroscopic x-ray system)

Catalogue Number: 10308191

ARTG Number: 102180
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/03/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 1800 310 300 - Siemens Technical Support Centre