| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00168-1 |
| Product Name/Description |
ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators
Serial numbers equal to or higher than 3094
ARTG Number: 165502 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens have identified that incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide. This can happen if the slide, on which the sensors used to detect the rotational collimator position are mounted, is not in its fully latched position. If the user is not aware of the incorrect values the patient can be mistreated by dose at the wrong location.
Siemens were also made aware of a defective weld seam at overhead suspensions. Due to such a defect the weld seam might break and the overhead suspension might fall down. This can lead to a severe injury of the patient or any other person. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is undertaking hardware updates regarding the collimator position detection and improper weld seam at overhead suspensions.
To keep the sensor slide in its latched position, a locking plate will be mounted to the sensor slide. This will significantly reduce the risk that the sensor slide might be mechanically misaligned and cause incorrect values being displayed for the rotational collimator position.
As reinforcement, a bracket will be added to the overhead suspension to ensure the stability of the connection. This will prevent the overhead suspension from falling down.
This action was closed on the 25/09/2018. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |