| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00628-1 |
| Product Name/Description |
Medtronic Navigation Planning Station
Planning Station, StealthStation S7
Part Number: 9734048
Planning Station, Plus
Part Number: 9730755
ARTG Number: 126293 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Where planning station computers have been upgraded or replaced, the new computers may not have a system-level serial number label. This could affect traceability of the devices. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Medtronic representative will be on site to confirm if the Planning Station has its original serial number label and apply the correct label if needed. This action has been closed-out on 11/02/2016. |
| Contact Information |
02 9857 9179 - Medtronic Regulatory Affairs |