Affera Prism-2 Integrated Mapping System
Affera Prism-2 Integrated Mapping System Recall Summary Medtronic is recalling the Affera Prism-2 Integrated Mapping System (Model AFR-00016) with software versions 2.3.1 and 2.3.2 due to multiple software problems. The affected software may cause loss of case data, mapping inaccuracies, temporary loss of functionality, procedure delays, system instability, or failure to launch after a hard reboot. This recall affects hospitals, pharmacies, and laboratories in New Zealand.
- Recalling firm
- Medtronic New Zealand Limited
- Product
- Affera Prism-2 Integrated Mapping System. [Device]. Model: Model - AFR-00016. Affected: Affected software - 2.3.1, 2.3.2
- Reason
- 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
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-02
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/fef0a1eb-303a-455b-9665-e37b47fb10a6