| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00812-1 |
| Product Name/Description |
ViewPoint 6 Versions 6.2, 6.2.1, 6.3 and 6.31 including OB Pro-Expert Reporting (Ultrasound image management software)
ARTG Number: 178864 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements. The ductus venous PIV measurement can be incorporated into the first trimester risk assessment for chromosomal abnormalities. In case of negative flow patterns, the ViewPoint calculated Doppler PIV for veins could be incorrect, leading to a false high risk for trisomy 13, 18, and 21. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to discontinue use of venous PIV for making any clinical decisions, in particular, discontinue use of the ductus venous PIV for first trimester risk assessment. GE Healthcare will be providing a software upgrade as a permanent fix. |
| Contact Information |
1800 659 465 - GE National Call Centre |