Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23177 |
| Brand Name: | Fujifilm ProSolv (Synapse CV) Cardio Software |
| Model: | versions 4.0.2 through version 6.0.4.1 (Synapse CV). |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Fujifilm NZ Limited 2c William Pickering Drive Albany Auckland |
| Contact Information: | 0800 242 646 |
| Manufacturer: | Fujifilm Medical Systems USA Inc |
| Issue: | The manufacturer has become aware of a malfunction in the system where inconsistent Mitral Valve Mean Pressure Gradient values are being reported. The values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the Synapse CV measurement tools. Multiple traces measured on the modality and transmitted to Synapse CV are not affected. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/6/2018 |
