GE Medical Systems, LLC recalls SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to…

Recall date

October 3, 2018

Source

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

Recall number

Z-0236-2019

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.

Why it was recalled

A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.

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

What was recalled

SIGNA Architect system Product Usage: The Signa Architect system 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 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.