| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00334-1 |
| Product Name/Description |
Elekta Integrity Digital Linear Accelerator, version 1.1
ARTG Number: 191025 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
If the "static tolerances" in the calibration files (loaded database) for the unwanted movement during the beam delivery are incorrect, the unwanted movement may not terminate treatment. This is only a problem if a malfunction such as a brake failure or an equivalent fault occurs during beam delivery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising that the solution to the problem is to apply the Integrity 1.1 Static Tolerance Updater Tool. This tool will need to be re-applied, if a new Linac license is applied in the future. A complete solution will be included in the next release of the software. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |