Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20411 |
| Brand Name: | Medtronic O-arm O2 Imaging System X-ray system |
| Model: | B1-700-02000, B1-700-00027 & B1-700-00028 |
| Affected: | |
| Software version: | Software Version 3.1.x, Software Version 3.2 |
| 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: | The O-arm® system requires updates in order to maintain compliance with applicable performance standards. Specifically, 1.Certain aspects of the technical information in the Instructions for Use document require clarification. 2.Radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements. 3.The O-arm System X-ray technique factor display accuracy related to mA might not be compliant to the system specifications |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 26/7/2016 |
