Recall Z-1943-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE
| Date | Aug 9, 2013 (initiated Nov 21, 2011) |
| Status | Terminated |
| Reason | Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems. |
| Root cause | Software design |
| Action | GE Healthcare communicated internally to their Service Team the directions for completing the correction on the customers' systems. GE Healthcare's recall strategy was to update all affected systems that were distributed. At this time,Week of 02/06/2012, deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2608 or email paulcorrigan@ge.com. |
| Quantity | 7016 (2919 US; 4097 OUS) |
| Distribution | Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN RE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE Medical Systems, Jan 24, 2002 |
| K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM General Electric Co., Mar 28, 2003 |
| K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co., Apr 14, 2004 |
| 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 |