Recall Z-3022-2017 · LNH System, Nuclear Magnetic Resonance Imaging

GE Medical Systems, LLC

Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the stru

Date	Aug 2, 2017 (initiated May 11, 2017)
Status	Terminated
Reason	Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Root cause	Mixed-up of materials/components
Action	Consignees received a written recall notice dated 05/17/2017 notifying them of a correction to all units using an Uninterruptable Power Supply. Consignees were instructed not to unplug the unit and to continue normal use. Units with the Eaton 9130 Uninterruptable Power Supply connected to the MR operator console would receive a correction at no charge. This would involve possibly replacing the power cable. GE Representatives will be contacting consignees to arrange corrections. Any questions can be directed to GE Healthcare Service at 1-800-437-1171 or your local service representative.
Quantity	68 units in total
Distribution	US Nationwide in the states of : AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI
FDA record	Open on fda.gov

510(k) clearances named in this recall

K083147	DISCOVERY MR450 Ge Medical Systems, LLC, Nov 4, 2008
K132376	DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T Ge Healthcare (Ge Medical Systems, LLC), Nov 15, 2013
K142085	DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T Ge Medical Systems, LLC, Sep 26, 2014
K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC, Jun 9, 2016