| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01290-1 |
| Product Name/Description |
Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
ARTG Number: 191025 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values. 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
If the treatment table, gantry or collimator calibration is incorrect, and the user does not perform the recommended QA procedures, it can cause clinical mistreatment, with errors up to 6cm could go undetected and repeated over a number of fractions |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As an interim measure, Elekta is recommending users perform the daily QA procedures as per the Instructions for Use (IFU) and perform a daily check to ensure the magnitude and direction of the treatment table movements are correct. If a user has X-ray Volume Imager (XVI), Elekta is recommending users perform the QA procedures as per the XVI IFU and perform the daily phantom scan.
All users of Integrity 3.1 software will be informed of a mandatory upgrade to software version 3.2 upon its release in February 2014. This action has been closed-out on 18/02/2016. |
| Contact Information |
02 8907 1820 - Elekta |