| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00504-1 |
| Product Name/Description |
Synapse Cardiovascular (CV) Software
Software versions 4.0.2 to 6.0.4.1
ARTG Number: 164422
(Fujifilm Australia Pty Ltd - Picture archiving and communication system, software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
FUJIFLM 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.
To date, there have been no reported patient injuries as a result of this issue. This malfunction does not impact the Advances Reporting System and there have been no reports of any other measurements or calculations being affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package.
If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter.
This issue has been corrected in Synapse CV 6.1.0 and higher versions |
| Contact Information |
03 9221 4200 - Fujifilm Australia |