| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01486-1 |
| Product Name/Description |
Brainlab Navigation System Spine & Trauma 3D
Serial Numbers: XXXXXXXX-19154-03 and XXXXXXXX-19154-04
ARTG Number 96517 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Brainlab has determined that due to a human error at a Brainlab supplier, an unknown number of items within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
Due to this manufacturing error the required reproducible rigid fixation between DrapeLink C-arm Array and Adapter cannot be ensured in all cases.
|
| Recall Action |
Recall |
| Recall Action Instructions |
Brainlab is advising users to isolate units with the specified serial numbers from use. A Brainlab Customer Support Representative will contact customers to arrange a service visit to collect and replace the potentially affected item.
This action has been closed out on 17/10/2018 |
| Contact Information |
02 9424 3800 - Brainlab Australia |