Events

Recall of 550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)

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-2014-RN-00455-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00455-1
  • 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
    The following safety issues have been identified with the 550 txt treatment table :1. in very rare instances, the actual table position may significantly deviate from the position at the table side control and the linac control console, but no interlock occurs.2. in sporadic cases the following issue for the table axis lateral, longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.
  • Action
    Siemens has developed a new version of the 550 TxT Treatment Table software. In addition to the software update, Siemens is providing 550 TxT Treatment Table Addendum for the IFU that describes new table error codes. The software update will prevent the failure mode by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)
  • Model / Serial
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)Lot Number: 7346534ARTG Number: 165502
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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