Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28619 |
| Brand Name: | NAV - Stereotactic surgery system, multi-purpose |
| Model: | |
| Affected: | Version - 2.2.8, 3.1.1, 3.1.2, 3.1.3 |
| 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 June 9, 2021, a complaint was reported to the manufacturer that during navigation in a Cranial Biopsy Procedure, the user may encounter an anomaly with the Biopsy Depth Gauge graphical display in the software. The software can enter a state where the Biopsy Depth Gauge is no longer synchronized with the rest of the navigational information on the screen and displays an inaccurate position of the biopsy needle. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/11/2021 |
