GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE,
FDA device recall Z-1305-2015 · posted 2015-03-20 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated March 9, 2015, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact your local service representative or call 800-437-1171 (available 24 hours a day).
- Root cause
- Software Manufacturing/Software Deployment
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 9,369 (2,937 US, 6,432 OUS).
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including PR, GU and DC., and to the countries of: ALBANIA. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVI
- Date initiated
- 2015-03-09
- Date posted
- 2015-03-20
- Date terminated
- 2015-09-08
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 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 |
| 1.5T INFINITY TWINSPEED MR SYSTEM (K012200) | GE Medical Systems | 2001-08-03 |