| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00962-1 |
| Product Name/Description |
Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)
Product Codes: 41735 & 41730A |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
Manufacturing tolerance's of the Standard Cranial Reference Array influence the actual position of its marker spheres. The differences between the individual arrays are very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery.
This recall action was not notified to the TGA before it was initiated by Brainlab Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to follow work around instructions and will provide a hardware update to correct the issue. |
| Contact Information |
02 9460 6688 - Five Corners |