Events

Recall of Artis Q/Q.zen systems

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-00261-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00261-1
  • 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
    It is possible that an electrical connection in the equipment cabinet has not been installed correctly. in potential fault scenarios (e.G. if several live wires become defective) and under certain conditions, this may prevent a safety mechanism on the system side from taking effect, thus compromising the electrical safety of the system.
  • Action
    Siemens is inspecting and correcting any affected units. This action has been closed-out on 1/06/2016.

Device

Artis Q/Q.zen systems
  • Model / Serial
    Artis Q/Q.zen systemsAll lot numbersARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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