GE Healthcare, LLC recalls Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal…

Recall date

January 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1188-2017

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Worldwide Distribution- US (nationwide) including states of: CA, DC, IL, MN, MO, NY, SC, TX, WI, WV; and countries of: Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and Uruguay.

Why it was recalled

Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Discovery MR450 The systems 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 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.