Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28370 |
| Brand Name: | Cardiac Mapping and Workstation System with Accessories |
| Model: | |
| Affected: | software versions 1.0.1, 1.0.2, and 1.1 |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Brand Name: | Computer application program |
| Model: | |
| Affected: | software versions 1.0.1, 1.0.2, and 1.1 |
| Software version: | |
| Recalling Organisation: | Abbott Medical New Zealand Limited 4 Pacific Rise Mt Wellingtion Auckland 1640 |
| Contact Information: | 0800 756 269 |
| Manufacturer: | St Jude Medical (USA) |
| Issue: | The manufacturer is advising customers using EnSite X Display Workstation with software versions 1.0.1, 1.0.2, and 1.1 that there is a potential issue with the optional respiration compensation feature that may lead to unstable catheter tracking and uncertainty regarding the location of the catheter in the heart. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/9/2021 |
