Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24704 |
| Brand Name: | Sequoia Cypress |
| Model: | ACUSON SC2000 VB20 and VB21 and the eSie Flow software (SW) license |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Medical Solutions USA Inc |
| Issue: | With the advent of 3D echocardiography, there are advances being made to improve workflow by automating quantification of stroke volume (SV) using three- dimensional volume color flow Doppler (3D-VCFD) utilizing the velocity information inherent to color doppler data. This is to inform eSie Flow software users that the eSie Flow quantification results are calculated assuming a 0° angle, for all angles of acquisition. eSie Flow does not correct for the angle of the blood flow in software versions VB20 or VB21. The standard of care as defined by the American Society of Echocardiography (ASE),American Heart Association (AHA), and European Society of Echocardiography (ESC) for evaluating valvular regurgitation requires the use of multiple sources of data to diagnose the disease classification. Therefore, the manufacturer remind users of the eSie Flow software that quantification results acquired from automated 3D-VCFD echocardiography have not yet been established |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/6/2019 |
