FDA-Device2018-10-31Class II
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, h
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.
Sold states
Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.
Affected count
4 units
Manufactured in
3200 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0236-2019More GE Medical Systems, LLC recalls
- FDA-Device2026-07-22GE Optima XR200/220/240amx radiography systems recalled for potential arm drop hazard
- FDA-Device2026-06-24GE Giraffe OmniBed infant bed recalled for detachable fastener hazard
- FDA-Device2026-06-24GE Giraffe OmniBed infant incubator recalled for loose fastener risk
- FDA-Device2026-06-24GE Giraffe OmniBed Carestation recalled for loose fastener risk in infant incubator
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief