Events

Recall of AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubes

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-2016-RN-01474-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01474-1
  • 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
    For axiom artis systems with software version vb35e and megalix x-ray tubes, the semi-automatic focus switch may in cases of a type of defect in foci "small" and "micro" (if present), does not work as intended when pressing the footswitch multiple times. this focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.This can result in the spontaneous malfunction of the active (micro or small) focal spot and a loss of imaging. while the manufacturer is not aware of any patient injuries, under the above circumstances this issue can cause a loss of the fluoroscopy functionality and may lead to a situation where the clinical procedure has to be aborted, rescheduled or the patient needs to be relocated to a functioning system.
  • Action
    A software update will correct the above mentioned issue. After the update, the Artis system will switch again semi-automatically to a functioning focal spot for all focus defects, enabling images to be displayed until the current procedure comes to an end. Users are advised that: - For system operation with a 2-foci Megalix X-Ray tube, it is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program. - For system operation with a 2-foci Megalix X-Ray tube, It is still possible to perform image acquisition with the large focus after manual selection of a corresponding organ program. - There should be standard emergency procedures in place in case of system failures.

Device

AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubes
  • Model / Serial
    AXIOM Artis systems with s/w version VB35E and Megalix X-Ray tubesARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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