Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21996 |
| Brand Name: | Artemis Software Apps for & Patient Controller (Model 3875) |
| Model: | |
| Affected: | Clinician Programmer and Patient Controller and Proclaim IPG implantable pulse generator |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | St Jude Medical (USA) |
| Brand Name: | Artemis Software Apps for Clinician Programmer (Model 3874) |
| Model: | |
| Affected: | Clinician Programmer and Patient Controller and Proclaim IPG implantable pulse generator |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | St Jude Medical (USA) |
| Issue: | The manufacturer is advising customers that it is aware of instances in which the elective replacement indicator (ERI) in some devices has triggered earlier than intended. In these cases, the ERI alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (IPG). ERI alerts estimate battery life based on programmed device parameters and patient usage and are unique to each patient. It is important to be aware that this issue is an error in software calculation and is not an indication of the devices' actual battery performance. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 19/9/2017 |
