| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00010-1 |
| Product Name/Description |
Integrity R1.1, R3.0 and R3.1(digital linear accelerator)
ARTG Number: 191025 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
During the treatment table, gantry and collimator calibration procedures, it is possible to type the incorrect values or invert a value. If the user does not do the quality assurance (QA) procedures after the calibration, it is possible that the user will not find the error made during the calibration. This could result in delivering the treatment with the patient in the incorrect position resulting in clinical mistreatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are asked to undertake QA procedures in accordance with the instructions for use (IFU) for Integrity, Precise Table and X-ray Volume Imager (XVI). Users will be informed of the mandatory software upgrade upon its release (expected early 2014) which will mitigate the issue. |
| Contact Information |
02 8907 1800 - Elekta Pty Ltd |