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 imaging. The nucleus detected is hydrogen.
FDA Recall Z-1492-2012 · Posted 2012-05-04
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2012-04-12
Date Terminated2012-08-09
Product Quantity41
Reason for Recall
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.