Events

Recall of Artis zee biplane and Artis Q biplane systems

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-2017-RN-01126-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01126-1
  • 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 has identified a screw connection in the ceiling mount consisting of 12 screws might not have been attached and fastened according to the quality standards for a specific number of artis zee/q biplane systems. the connection is located within the rotation unit of the second plane.If such screws are not fully tightened in accordance with the specified values, single screws between the c-arm structure of the second plane and its ceiling carriage may become loose. if various screws become loosened over time, this may lead to a recognisable wobble of the c-arm, especially during fast movements. this may result in an acquired image/3d which does not allow for clinical appraisal, resulting in additional x-ray exposure for a patient.There is also the remote possibility that if, after an extended time period, all screws become loosened, parts of the second plane mechanics may become detached from the ceiling carriage of the system, and could hurt the patient and/or personnel.
  • Action
    Siemens will arrange for all potentially affected systems to be examined. All affected systems will be modified so as to have the screws tightened.

Device

Artis zee biplane and Artis Q biplane systems
  • Model / Serial
    Artis zee biplane and Artis Q biplane systemsCatalogue Numbers: 10094141 and 10848282ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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