Recall Z-0815-2007 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Medical Systems LLC
GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
| Date | May 18, 2007 (initiated Jun 1, 2006) |
| Status | Terminated |
| Reason | To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software. |
| Root cause | Other |
| Action | The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006. |
| Quantity | 30 units |
| Distribution | Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM General Electric Co., Apr 14, 2004 |