| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00134-1 |
| Product Name/Description |
RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B including some service packs
Build Numbers: 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483
ARTG 195288
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Radiation therapy treatment planning system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/01/2022 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been found with the display of the secondary image sets in a side-by-side view in RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B including some service packs. The primary image set may be displayed instead of the secondary image set.
A 4D image set can be shown as a “cine loop”, running through the 3D image sets as a sequence. If a cine loop is started in the view of the primary image set, the same cine loop will be displayed in all side-by-side views, i.e., also in the view of the secondary image set, regardless of which image set is selected as secondary.
To date, this issue has not caused any patient mistreatment or other incidents. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised this issue is resolved in RayStation/RayPlan versions 10A and higher. If customers wish to continue using affected versions, all users must maintain awareness of the issue and its workaround. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
In the interim, users are advised not to change the primary image set while the cine loop is running. If the primary image set has been changed while the cine loop is running, restart RayStation/RayPlan to restore correct behaviour.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9006 1662 or AUNZvigilance@ul.com - Emergo Australia |