FDA-Device2020-02-05Class II
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.
GE Healthcare, LLC
Hazard
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.
Sold states
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected count
62 (30 US, 32 OUS) total devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0877-2020Don't want to check this manually?
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