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Terminated

Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner 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 structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

FDA Recall Z-3021-2017 · Posted 2017-08-02

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2017-05-11
Date Terminated2020-09-09
Product Quantity68 units in total

Reason for Recall

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123417BRIVO MR355, OPTIMA MR360Ge Hangwei Medical Systems Co., Ltd. · 2013-01-17K120778BRIVO MR355Ge Hangwei Medical Systems Co., Ltd. · 2012-03-27K103330BRIVO MR355, OPTIMA MR360Ge Hangwei Medical Systems Co., Ltd. · 2011-02-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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