Events

Recall of Sensis system

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-2017-RN-00521-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00521-1
  • 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
    In sensis systems, a computer that is extremely dusty can cause problems when starting the system. in rare cases, it can cause the sensis to fail. the system's functions cannot be used in the event of a failure and as a result, clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
  • Action
    Siemens is currently working on a solution and will update users in the second quarter of 2017. In the interim, users are requested to conduct a system check to ensure that the system is functioning properly prior to performing an examination. In the event that the system fails to start within the time and parameters described in the operator manual, users are requested to notify Siemens Service, and terminate, restart or transfer clinical treatment to a functioning system. Users are to ensure that standard emergency processes are in place for implementation in the event of a system failure.

Device

Sensis system
  • Model / Serial
    Sensis systemCatalogue Numbers: 6634633, 6623974, 10764561 and 11007641ARTG Number: 273953
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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