| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00128-1 |
| Product Name/Description |
RayStation and RayPlan
Model Numbers: RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7)
Serial Numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19
ARTG Number: 195288
(Emergo Asia Pacific Emergo Australia - Radiation therapy treatment planning system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that when more than one beam is defined on the same isocenter, the Center Beam in Field (CBF) affects all beams in a way that the user may not expect.
After using CBF, the resulting fields are clearly displayed in RayStation/RayPlan for review and approval. However, one mistreatment incident using the CBF functionality has been reported where the user failed to review the resulting beam apertures before treatment delivery. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Emergo will be contacting users to update to the next version of RayStation/RayPlan.
In the interim, users are advised:
· Be aware that Center Beam in Field affects all beams that share the same isocenter and that apertures may be modified in a way not intended.
· Do not use Center Beam in Field after having created an opposed beam. If an opposed beam has been created, delete the opposed beam and use Center Beam in Field on the remaining beam. Then recreate the opposed beam.
This action has been closed out on the 21/11/2018. |
| Contact Information |
02 9006 1662 - Customer Service Support |