| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00375-1 |
| Product Name/Description |
Elekta Integrity R3.0 Digital Linear Accelerator
ARTG Number: 191025 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. A fault will occur is the loaded database is incorrect, and could cause clinical mistreatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Elekta is advising that the solution to this problem is to upgrade to IntegrityR3.1 as soon as it is available. An updater tool will be available within the next few months and will be Field Safety Modification number 200 02 502 030. This tool is a CD disk that Elekta Service will use on each product to check tolerances and it will adjust if necessary. This is a one-time check unless there is a change to the configuration, such as a new license for the LINAC and then a new check will be needed. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |