| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00733-1 |
| Product Name/Description |
RayStation and RayPlan
Multiple Model and Lot Numbers
ARTG Number:195288
(Emergo Asia Pacific T/a Emergo Australia - Radiation therapy treatment planning system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified by Emergo that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. To the best of our knowledge, the issue has not caused any patient mistreatment. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Emergo is requesting that users:
Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
- Carefully review all beam model parameters before commissioning.
- Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
- Review any existing photon beam models to ensure that the actions above have been properly performed.
Please educate physics staff about these user responsibilities.
Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.
This action has been closed out on 11/10/2019 |
| Contact Information |
02 9006 1662 - Emergo Australia or AUNZvigilance@ul.com |