Z-0874-2020 Class II Terminated
FDA device recall Z-0874-2020 was initiated by GE Healthcare, LLC on December 23, 2019 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated December 11, 2020). Affected quantity: 62 (30 US, 32 OUS) total devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 23, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 (30 US, 32 OUS) total devices
Product Description
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.
Reason for Recall
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.
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.
Code Information
Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672