GE Healthcare, LLC recalls SIGNA Premier Nuclear Magnetic Resonance Imaging System - Pr
Recalled Product
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Hazard / Issue
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.
Issued by
FDA
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