Events

Recall of Ceiling system for Artis Zee System (Fluoroscopic angiographic digital 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-01163-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01163-1
  • 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
    Cables in the cable harness of the ceiling carriage may have received wear and tear or damage resulting in loss of system movement or loss of complete functionality. siemens technical specialists have advised that this issue could result in a limited or total loss of functionality with regards to the system movement. the cable damage caused by this issue would only affect system movement, not the imaging. however, as this type of system may be used during procedures for the placement of catheters, pacemakers, transcatheter aortic valve implantations etc. the loss of system movement may limit the available imaging during this type of procedure.
  • Action
    Siemens is inspecting all potentially affected cables and installing an additional cable guide system to prevent wear if necessary.

Device

Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)
  • Model / Serial
    Ceiling system for Artis Zee System (Fluoroscopic angiographic digital x-ray system)Catalogue Number: 10094137Serial Numbers: 146367, 146674, 146718, 146880, 146910, 146926, 146967, 147054, 147092, 147095, 147101, 147102, 147518All systems equipped with a ceiling stand with serial numbers from 10701 to 11557ARTG Number: 120177
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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