Recall Z-0935-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
| Date | Mar 11, 2013 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Field Safety Notice dated May 5, 2011, to all affected customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. Customers were instructed to open only one patient report at a time when editing a report in SR Viewer. US Customers did not receive a customer letter, however all US systems have been updated. For questions customers were instructed to contact their local Sales/Service Representative. For questions regarding this recall call 262-513-4122. |
| Quantity | 4026 (1672 US; 2354 OUS) |
| Distribution | Worldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC, Sep 21, 2005 |
| K052978 | GE 1.5T SIGNA HDE MR SYSTEM Ge Medical Systems, LLC, Nov 9, 2005 |
| K081028 | SIGNA 3.0T MR750 SYSTEM Ge Medical Systems, LLC, Apr 25, 2008 |
| K083147 | DISCOVERY MR450 Ge Medical Systems, LLC, Nov 4, 2008 |
| K091536 | OPTIMA MR450W Ge Medical Systems, LLC, Jul 17, 2009 |