Events

Recall of syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQ

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-2016-RN-01088-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01088-1
  • 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
    Syngo rt therapist is specified in a way that it will always use the plan unique identifier (uid provided by ois mosaiq. if a plan has changed many times and one of the previous changes is reverted, mosaiq will apply the uid of the previous plan, before the change has been made in the past. in this case, from a treatment point of view mosaiq sends a previously used plan uid that may cause the rt therapist to choose an out-dated treatment plan according to the plan uid provided by mosaiq. as a consequence all performed changes on rt therapist, for example setup changes like added pauses or gating flags, will not be active. this behaviour might lead to a collision or a mistreatment.
  • Action
    Siemens has notified users that from a syngo RT Therapist software point of view, it is not possible to distinguish between correct and incorrect UID provided by MOSAIQ. Therefore no technical solution for this issue can be provided by Siemens. The “RT Therapist Release Notes for MOSAIQ” have been updated with the according information in chapter 10.1. This action has been closed out on 16 June 2017.

Device

syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Inform...
  • Model / Serial
    syngo RT Therapist 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.2.110 in combination with Oncology Information System (OIS), MOSAIQCatalogue Numbers: 8162815 and 8168754ARTG Number: 171515
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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