| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00585-1 |
| Product Name/Description |
MEVATRON, PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
ARTG number: 165502 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of Siemens that one of their customers used FILM mode for image acquisition although it was not correctly calibrated, resulting in an overdose to several patients. FILM mode is a separate beam (dose set 8) and needs to be calibrated and verified prior to being used. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing additional calibration procedures and asking customers to make sure it is implemented. The physicist responsible for the system has to verify necessary system dosimetry for all beams used for patient treatment and imaging, in particular following a service intervention. Additionally, the necessary departmental QA procedures need to be followed. Siemens will also distribute information provided in the customer letter as an addendum to the user documentation. |
| Contact Information |
1800 310 300 - Siemens Technical Assistance |