Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15011 |
| Brand Name: | Medtronic Navigation Framelink Software |
| Model: | 9734047 |
| Affected: | all lots of version 5.4 |
| Software version: | 5.4 |
| 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: | Manufacturer has identified that the use of high resolution exams (greater than 256 x 256) under certain use conditions may cause the Look-Ahead view labels to show user selected depths (displayed) , but the corresponding images are shown at a depth twice the selected distance. Under these conditions visulaization of the planned trajectory could show the image at the incorrect depth. Further internal investigation discovered that the use of high resolution exams (256 x 256) under certain use conditions may cause a similar discrepancy between the exam image and the displayed measurement or overlay. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/7/2013 |
