GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinit
FDA device recall Z-2339-2015 · posted 2015-08-05 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
- Action taken
- GE Healthcare sent an Urgent Medical Device Correction letter dated July 10, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 82 (39 USA; 43 OUS)
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to UNITED ARAB EMIRATES, ARGENTINA, BRAZIL, INDIA, EGYPT, CHINA, FINLAND, FRANCE, UNITED KINGDOM, HUNGARY, JAPAN, INDONESIA, KOREA, MEXICO,
- Date initiated
- 2015-07-10
- Date posted
- 2015-08-05
- Date terminated
- 2015-11-19
- 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 |