Events

Recall of Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly

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-00550-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00550-1
  • 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
    Due to a production fault in a specific production lot of the triple-focus x-ray tube assembly, there is a possibility that the "small focus" may fail. if this occurs, no further radiation release will be possible from this focus source. the "large focus" and "micro focus" will still be operational.
  • Action
    This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016.

Device

Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly
  • Model / Serial
    Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assemblyCatalogue/Lot numbers: X-ray tube assemblies 10144184 and 10145086 from a specific production lotARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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