Device 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.
Z-0874-2020
Product summary
- Event
- Event 84655
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 (30 US, 32 OUS) total devices
- Official record key
device-enforcement:Z-0874-2020
Official wording
Reason: 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.
Code information: Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672
Distribution pattern: Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
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.