Events

Recall of Artis Zee Systems equipped with a card collimator

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-00077-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00077-1
  • 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
    At the card collimators of these systems, a dislocation of the scatter radiation filter inside the card collimater may occur.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Action
    Siemens is providing a replacement filter to fix the issue.

Device

Artis Zee Systems equipped with a card collimator
  • Model / Serial
    Artis Zee Systems equipped with a card collimatorArtis Zee material numbers: 10094135, 10094137 and 10094141Card collimator material numbers: 10092591, 10092593, 10092601, 10092631 and 10092632ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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