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 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-2015-RN-00818-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00818-1
  • 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
    Siemens have received reports that under certain circumstances, when starting the system up or reconnecting the c-arm cable to the main unit, the error 5000/243 “no x-ray - fd re-initialises” may occur. the error refers to a potential hardware malfunction of the cios alpha c-arm x-ray system that may occur when starting the system up or reconnecting the c-arm cable to the main unit. when this occurs, the system will become inoperable until the affected part is replaced.
  • Action
    Siemens is planning to release a modification for the Cios Alpha mobile C-arm x-ray system that will resolve the above-mentioned potential malfunction. As soon as the modification is available, a Siemens service engineer will contact customers to schedule implementation of the modification for your system. Siemens is providing the following instructions to minimise the risk of this issue: · Ensure that the system is ready after the startup · Ensure that the error 5000/243 is not displayed, neither as message box nor in the FLC status bar (lower left side of the left monitor) · In general, avoid disconnecting and reconnecting the C-arm cable during or shortly before starting a procedure. This action has been closed-out on 31/08/2016.

Device

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

Manufacturer

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