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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 GE Healthcare Australia Pty Ltd
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