Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19028 |
| Brand Name: | Biosense Webster CARTO 3 System, VISITAG Module |
| Model: | FG-5400-00 |
| Affected: | All units |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Biosense Webster (Israel) Ltd |
| Issue: | The manufacturer has issued a notice reinforcing the following warning which appears in the CARTO 3 System instructions for use: The CARTO VISITAG Module provides access to data collected during the application of RF endergy. The data does not indicate the effectiveness of RF energy application. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 7/9/2015 |
