Recall Z-1492-2012 ยท MOS Coil, Magnetic Resonance, Specialty
GE Healthcare, LLC
GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of receive-only RF surface coils designed for use with 1 .5T MRI systems manufactured by GE Healthcare. The GEM Option for 1 .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone ima
| Date | May 4, 2012 (initiated Apr 12, 2012) |
| Status | Terminated |
| Reason | GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an improperly torqued gradient connection exists, it may cause the gradient lead to produce excessive heat. If a second and compounding issue of improperly routed Rear Pedestal Air Supply Hose is also present, routed in such a way to cause the hose to come in contact with the overheated gradient lead |
| Root cause | Nonconforming Material/Component |
| Action | GE Healthcare is not sending a Communication Letter to customers. There is no plan to contact customers with an affected Optima MR450W with GEM system. A GE Healthcare Field Service Engineer will be dispatched to sites to inspect and correct all potentially affected systems. As an effectiveness check, GE Healthcare will track all service requests for the field action to completion. For any questions or additional information, call 262-548-2608. |
| Quantity | 41 |
| Distribution | Worldwide Distribution - USA (Nationwide) including the states of :CO, FL, IA, MA ,MN, NJ, NY, NC, OH, TX. and the countries of BRAZIL., BRITAIN, FINLAND, FRANCE, GREAT GERMANY, ITALY, SAUDI ARABIA, SWEDEN, SPAIN, KUWAIT, and SWIITZERLAND. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103335 | GEM OPTION FOR 1.5 MRI SYSTEMS GE Healthcare, Mar 7, 2011 |