GE Medical Systems, LLC: Medical Device Recall in 2018 - (Recall #: Z-0236-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 3, 2018

Date Posted: October 31, 2018

Recall Number: Z-0236-2019

Event ID: 81348

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4 units

Code Information:

Model number: 5388807-100, Serial number (System ID number ): U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated