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

Recalled October 31, 2018 · FDA recall Z-0236-2019 · GE Medical Systems

Hazard

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. · FDA Class II

Units

4 units

Sold at

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

Description

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.

Product

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.

Manufacturer(s)

GE Medical Systems, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →