SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WIT
FDA device recall Z-1943-2013 · posted 2013-08-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 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
- Date initiated
- 2011-11-21
- Date posted
- 2013-08-09
- Date terminated
- 2014-10-22
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293) | Ge Medical Systems, LLC | 2005-09-21 |
| GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM (K041476) | Ge Medical Systems, LLC | 2004-06-17 |
| GE SIGNA 3.0T WITH EXCITE MR SYSTEM (K040444) | General Electric Co. | 2004-04-14 |
| GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM (K030874) | General Electric Co. | 2003-03-28 |
| SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY (K013636) | GE Medical Systems | 2002-01-24 |