Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00046-2
Product Name/Description Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis (AHSA) v1.0.0
(Used for Linac based radiation treatment planning of cranial, head and neck, and extracranial lesions)

ARTG Number: 230067
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 15/01/2016
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue Brainlab Image Fusion is used for co-registration of medical images. When loading the fusion result in affected devices, under specific circumstances, the fusion result stored by Image Fusion is disregarded. Instead the image datasets are co-registered based on the scanner-inherent fusion that can potentially result from acquiring the images in one imaging session. In consequence, the image datasets may become shifted e.g. organs at risk or planning target volume, may become shifted in relation to their anatomical position.

While using Brain Metastases 1.0.0, if the shifted objects are not recognised by the user before the plan is used for treatment and the deviation exceeds clinically acceptable limits, this could result in ineffective radiation treatment.

While using AHSA 1.0.0, the incorrect information displayed can have an effect on clinical decisions. In a worst case scenario, this can mislead the clinician in assessing the extent of tumour resection during surgery.
Recall Action Recall for Product Correction
Recall Action Instructions Brainlab will implement a software update for the affected systems. In the interim, users of affected systems are advised to adhere to the following:

If possible do not use image datasets with an identical coordinate system (i.e. same frame of reference information), unless the scanner fusion is acceptable to be approved in Image Fusion.
Always carefully review and verify the fusion result and all objects for correctness and validity in Brain Metastases or Adaptive Hybrid Surgery Analysis. Specifically if the error message is displayed by the software, review the position of all objects in the CT used for treatment planning and in the image datasets with the same frame of reference. Please note that the error will not be visible in SmartBrush, Image Fusion and DICOM Viewer. Always verify the fusion result and correct position of objects in Brain Metastases or Adaptive Hybrid Surgery Analysis.
Contact Information 02 9424 3800 - Brainlab Australia