Recall Z-2098-2013 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint provides the user the ability to including images, draw
| Date | Aug 27, 2013 (initiated Aug 7, 2013) |
| Status | Terminated |
| Reason | GE has recently become aware of a potential safety issue due to the incorrect calculation of the pulsatility index value (PIV) for venous flow measurements associated with obstetric reporting of the GE ViewPoint 6 system. The ViewPoint calculated Doppler PIV for veins could be incorrect. An incorrect calculation of the ductus venosus PIV could lead to false high risk for trisomy 13, 18, and 21, |
| Root cause | Software Design Change |
| Action | GE Healthcare sent An Urgent Medical Device Correction letter dated August 7, 2013 to all affected customers. The letter described the affected product, problem and instructed customers to discontinue use of venous PIV for making any and all clinical decisions. The letter informed customers that a GE service engineer will install a correction at no cost. For questions contact your local GE Healthcare Representative or call 877-644-3114 (US) and 49 (0)8153-9311-11(Europe/Asia) |
| Quantity | 225 |
| Distribution | Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: ANDORRA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, KUWAIT, MALAYSIA, Norway, OMAN, PALESTI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103458 | VIEWPOINT 6 GE Healthcare, Mar 4, 2011 |