Events

Field Safety Notices about Cios Alpha mobile C-Arm system

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Healthcare GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    1) if the system language is set to english and the yyyymmdd date format 5 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 when the dvd icon on the flc status bar is blinking. in this case error messages wili 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.

Device

Cios Alpha mobile C-Arm system

Manufacturer

Siemens Healthcare GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS