Recall Z-2266-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx famil
| Date | Sep 23, 2013 (initiated Apr 9, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit |
| Root cause | Software design |
| Action | Customers were sent two GE Healthcare "Urgent Medical Device Correction" letters one dated April 9, 2013, and the other May 22, 2013, each addressing one of the 2 groups of MR Products involved in the recall. The letters were addressed to Hospital Administrators / Risk managers, Radiology Department Mangers and Radiologists. The letters described the Safety Issue and provided Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service r |
| Quantity | 1,246 (521 US and 725 OUS) |
| Distribution | Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081028 | SIGNA 3.0T MR750 SYSTEM Ge Medical Systems, LLC, Apr 25, 2008 |
| K083147 | DISCOVERY MR450 Ge Medical Systems, LLC, Nov 4, 2008 |
| K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, Sep 30, 2011 |
| K113490 | OPTIMA MR450W Ge Medical Systems, LLC, Jan 13, 2012 |
| K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT Ge Medical Systems, LLC, Sep 20, 2012 |