Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22541
Brand Name:NAV - O-arm Software Upgrade, Version 3.1
Model:All 3rd Edition, O-arm 1000 Imaging Systems.
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Breakaway Imaging LLC
Issue:In July 2017, the manufacturer Navigation rolled out routine SW Update 3.2.1. This change is in response to customer complaints and addresses several known software anomalies. The software anomalies were reported to affect system behaviour.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:29/1/2018
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