medical Class II Updated 2020-02-05

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

Distribution: Nationwide (United States)
Lot/Code Info: Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672
View official government recall

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