SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2020