| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00716-1 |
| Product Name/Description |
Frameless SRS QA Target Pointer (Component of Brainlab Stereotactic System used for patient positioning during stereotactic radiosurgery or radiotherapy procedures using a linear accelerator)
Product Number: 43410
Serial Number: 1223012002, 1223012007, 1223012008
ARTG Number: 121226 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
17/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been detected that the Pointer Cap with the engraved cross hairs may become loose even when only a moderate force is applied to the Pointer Cap. Due to the manufacturing tolerances specified the force to loosen the Pointer Cap may vary, depending on the individual Pointer Cap and Aluminium Pointer Rod assembly. If this occurs, most likely the Pointer Cap will detach completely, rendering the Target Pointer no longer usable. In a scenario that the Pointer Cap would loosen but not detach completely, a shift of the Pointer Cap of up to 2mm might remain unnoticed. Since the device is used for calibration and quality assurance of patient positioning technologies for radiation therapy treatments at a linear accelerator, this scenario might degrade the accuracy of the positioning solution used. |
| Recall Action |
Recall |
| Recall Action Instructions |
Brainlab is requesting users to inspect stock and quarantine affected devices. Replacement stock will be provided to affected customers. |
| Contact Information |
02 9424 3800 - Brainlab Australia |