| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00812-1 |
| Product Name/Description |
AlignRT Plus
ARTG 270213
(Vision RT Australia Pty Ltd - Patient positioning/tracking video camera system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
An update to the Australian Sponsor Address was initiated in February-2023, however this change was not communicated to the wider business at the time of occurrence, and therefore, incorrect labelling with the incorrect address for Vision RT Australia PTY has been applied to the device when shipped to Australia since 01-February-2023.
The Australian Sponsor company name and ARB number have not changed, and the support contact details have not changed. This change impacts the device applied labelling and Instructions for Use only. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers will receive new labels and instructions for how to apply these to current device for all Vision RT affected systems in the customer letter.
The Instructions for Use has also been updated to include the correct Australian Sponsor information and can be accessed through the myvisionrt.com portal. |
| Contact Information |
0420 602 143 - Sue Mckenna |