Recall Z-2339-2015 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
| Date | Aug 5, 2015 (initiated Jul 10, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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, NEW ZEALAND, CANADA, AUSTRALIA, ITALY, RUSSIAN FEDERATION, TAIWAN, and SOUTH AFRICA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM GE Medical Systems, Aug 3, 2001 |
| 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 |