Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17574 |
| Brand Name: | Medtronic StealthStation AxiEM or Fusion EM Surgical Navigation System |
| Model: | |
| Affected: | All units |
| 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: | Through testing conducted with these two products by Berchtold and Medtronic, when the lights are positioned according to Berchtold's Instructions for Use - at a distance at least one meter from the patient - there is no interference. When the lights are positioned closer to the patient, the resulting electromagnetic interference (EMI) causes the StealthStation® AxiEM™ or Fusion EM system to cease tracking and display "red status", which prevents navigation until the EMI is removed. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/10/2014 |
