Events

Recall of ARTIS pheno 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-2018-RN-00471-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00471-1
  • 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 an issue with artis pheno systems. if the c-arm is moved manually longitudinal to a fully extended position it may occur rarely, that the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the movement and can drop up to 20 mm (0.8"). this can happen during an ongoing procedure.If this issue occurs, the system performs a safety stop. all c-arm movements are blocked and can only be reactivated by a field service engineer.
  • Action
    Siemens are currently working on a solution to eliminate the root cause of the problem. In the interim, users are advised to avoid driving the C-arm into a fully extended longitudinal position. A fully extended longitudinal position is reached when the stand arms are almost completely stretched out.

Device

ARTIS pheno systems

Manufacturer

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