Recall Z-1511-2014 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images.
| Date | Apr 25, 2014 (initiated Apr 7, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow running on Advantage Workstation. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction" letter dated August 21,2013, to all affected consignees. The letter was addressed to Hospital Administrators /Risk Managers, Radiology Department Managers and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers were instructed until the issue is corrected on their system with the affected CardiacVX or CardiacVX Flow software for phase-contrast protocols customers use the fast CINE phase-contrast sequence with the magnitude weighting us |
| Quantity | 101 (1 US , 100 OUS) |
| Distribution | Worldwide Distribution - USA including IN and Internationally to AUSTRALIA, CANADA, CHILE, FRANCE, ITALY, JAPAN, KOREA, KUWAIT, NEW ZEALAND, PANAMA, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121762 | CARDIAC VX Ge Medical Systems, LLC, Jan 18, 2013 |