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U.S. Department of Health and Human Services

Class 2 Device Recall Optima MR450W with GEM.

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  Class 2 Device Recall Optima MR450W with GEM. see related information
Date Initiated by Firm April 12, 2012
Date Posted May 04, 2012
Recall Status1 Terminated 3 on August 09, 2012
Recall Number Z-1492-2012
Recall Event ID 61413
510(K)Number K103335  
Product Classification Coil, magnetic resonance, specialty - Product Code MOS
Product 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.
Code Information HM0227 HM0243 HM0245 HM0255 HM0290 HM0292 HM0296 HM0301 HM0315 HM0316 HM0321 HM0343 HM0271 HM0339 HMO293 HM0287 HM0263 HM0236 312 HM0322 HM0331 HM0332 357 HM0247 HM0250 HM0253 HM0261 HM0326 HMO300 HM0242 HM0249 HM0251 HM0254 HM0309 HM0310 HM0334 HM0338 HM0344 HM0347 HM0262 HM0323 
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MOS and Original Applicant = GE HEALTHCARE