Events

Recall of Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic 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-2013-RN-00966-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00966-1
  • 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 conditions, x-ray release on artis system version vc1x may get blocked. thepotential malfunction may only occur if:a) the system is ready for operation, andb) the c-arm was moved into the so called "patient transfer position" for patient transfer (in this position x-ray is blocked), andc) at the same time the c-arm is in "patient transfer position", a hardware failure in the ias (image acquisition system) is occurring.If the c-arm is moved out of the "patient transfer position" (the problem with the ias was solved by the system itself), x-ray remains blocked.This issue is known to have only occurred on a single system in the field.
  • Action
    If the failure mode occurs, customers are advised to urgently manually switch the system OFF ("System shutdown") then switch the system back ON again. The failure mode cannot be generally rectified by either executing the "System Restart" or "Application Restart" functions. The supplement to the Operator Manual with the above information is enclosed with the customer letters. The problem will be resolved during the next service update.

Device

Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)
  • Model / Serial
    Artis Systems running Artis VC1x software (Fluoroscopic angiographic diagnostic x-ray system)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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