Events

Recall of Cios Alpha mobile C-arm x-ray system

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2015-RN-00399-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00399-1
  • 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
    Under certain circumstances the following user actions may cause the system to freeze. ·when images were transferred from the left monitor to the right monitor (function a to b) during image acquisition (i.E. radiation on) or shortly before starting image acquisition·when acquisition of image was started while storing of scenes initiated by pressing the store button was still in progress·when scene replay was initiated either automatically or by pressing the “play” button (especially when pressing the “play” button more than once) while the storing of those scenes was still in progress·when image acquisition was initiated again before automatic replay of the last scene started·when finalized cd/dvds were used to store additional data·when radiation summary reports with more than 190 entries were being exported·when system restart was initiated when the error message “system blocked. turn system off/on” (error codes 215/80 and/or 208/80) was displayed.
  • Action
    Siemens has provided a workaround whilst a system modification is being developed which is expected for July 2015. This action has been closed-out on 11/08/2016.

Device

Cios Alpha mobile C-arm x-ray system
  • Model / Serial
    Cios Alpha mobile C-arm x-ray systemCatalogue number: 10308191ARTG number: 102180
  • Manufacturer
    Siemens Ltd

Manufacturer

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