| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01088-1 |
| Product Name/Description |
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
Catalogue Numbers: 8162815 and 8168754
ARTG Number: 171515 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |