| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00801-3 |
| Product Name/Description |
Agility (An integral beam limiting device used with linear accelerators)
ARTG Number : 196919 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
The Agility beam limiting device (BLD) does not support the use of dynamic multileaf collimator (DMLC) Apex at this time. Apex has not been integrated
or classified as compatible for use with the Agility. The use of these products together has not been verified or validated by Elekta and they must not be
used together. There are mandatory changes necessary to the Agility BLD interlock circuit to let you safely attach the Apex device. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The customers are advised not to use Apex with Agility as the combined use could cause fatal injury, clinical mistreatment or damage to the equipment. At this time, it is noted that no Australian customers currently have an Apex installed. |
| Contact Information |
02 8907 1800 - Elekta Regulatory Affairs |