Recall Z-0236-2019— GE Medical Systems, LLC

Name: FDA recall Z-0236-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-03

Class II · Terminated

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2018-10-03, terminated 2022-05-27. It names one FDA 510(k) clearance: K160618. 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.. Reason: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-10-03
Terminated: 2022-05-27
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC·cleared 2016-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.