Recall Z-0592-2010 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems, LLC
Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not
| Date | Jan 11, 2010 (initiated Oct 6, 2009) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p |
| Root cause | Software design |
| Action | GE Healthcare issues an "Important Product Information" letter dated October 23, 2009. The letter was addressed to Hospital Administrators, Managers of Radiology and Radiologists. The letter listed the Issue, Affected Product Details, Instructions, Product correction and Contact Information. For further information, contact GE Healthcare at 1-262-548-2731. |
| Quantity | 5460 |
| Distribution | Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN, ECUADOR, EGYPT, FINLAND, FRANCE, GEOR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC, Jun 17, 2004 |
| 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 |