Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24228 |
| Brand Name: | NAV - Stereotactic surgery system, multi-purpose |
| Model: | Synergy Cranial Software - 9733763 All versions, StealthStation S7 Cranial Software - 9735585 All versions |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Medtronic Navigation Inc |
| Issue: | On 15 October 2018, the manufacturer notified customers of a software error present in the StealthStation™ S7 and StealthStation™ i7 Synergy™ Cranial Software which could lead to inaccurate placement of a biopsy needle (Safety Alert, Medsafe reference 23704). Follow-up Action: The manufacturer has been working on a Software Upgrade to correct this issue which they hope will be ready for release in the second half of 2019. Two part Recall for Product Correction will apply: Part 1 (this action) – communicate that the SW update is in progress, and provide accounts with a laminated risk mitigation card to be attached to their system until the SW upgrade is available and installed on their system. Please note the manufacturer are not communicating any further or different information than what was communicated in the previous Safety Alert. The scope, issue, risks and mitigation instructions all remain unchanged. Part 2 – this will be the software upgrade. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2019 |
