| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00269-1 |
| Product Name/Description |
ExacTrac 6.0.3 Patient Positioning System (Image guided radiation treatment therapy patient positioning system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
When using multiple isocenters (multiple radiation treatment targets) within a single plan, if a specific workflow is used and certain variables relating the software timing and user interaction are met, ExacTrac v6.0.3 might position the patient to an unintended isocenter position. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Brainlab is requesting end users to avoid using treatment plans with multiple isocenters. If a plan with multiple isocenters cannot be avoided always close the patient ExacTrac after treatment of one isocenter is finished and reload the patient plan before selecting the next isocenter. Also, make sure to always select only one isocenter of the plan in ExacTrac in between opening and closing the patient. Brainlab will release a software update to correct the issue. Thia action has been closed-out on 28/01/2016 |
| Contact Information |
02 9424 3800 – Brainlab Customer Support |