Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36995 |
| Brand Name: | Affera Prism-2 Integrated Mapping System |
| Model: | Model - AFR-00016 |
| Affected: | Affected software - 2.3.1, 2.3.2 |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | Affera Inc |
| Issue: | The manufacturer has identified multiple software problems in the Affera Prism-2 Integrated Mapping System. The affected software may not perform as intended, potentially resulting in loss of case data, mapping inaccuracies, temporary loss of functionality, procedure delays, system instability, or failure of the application to launch following data corruption after a hard reboot |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/7/2026 |
