Z-1492-2012

GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of...

Name: Z-1492-2012 GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI systems is a set of...
Creator: GE Healthcare, LLC
Published: 2012-04-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2012-04-12 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of 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... on 2012-04-12. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1492-2012
Status: Terminated
Initiated: 2012-04-12
Posted: 2012-05-04
Terminated: 2012-08-09
Recalling firm: GE Healthcare
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.
Product code: MOS Coil, Magnetic Resonance, Specialty
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
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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

Product code MOS

K103335Class IIGem Option for 1.5 MRI SystemsGE Healthcare / cleared 2011-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)