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Health product recall

CIOS ALPHA (2016-02-23)

Starting date:
February 23, 2016
Posting date:
March 10, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57466

Affected Products

  1. CIOS ALPHA

    Reason

    Siemens is notifying customers of the following potential software issues with the Cios Alpha:

    1. 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.
    2. 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.
    3. Sporadically the system will not be ready for radiation during reconnection of the trolley to the main unit. A system reboot is necessary.

    Affected products

    1. CIOS ALPHA

    Lot or serial number
    • 11137
    • 11138
    Model or catalog number
    • 10308191
    Companies
    Manufacturer
    Siemens AG
    Wittelsbacherplatz 2
    Muenchen
    80333
    GERMANY