Z-0875-2020 Class II Terminated
FDA device recall Z-0875-2020 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 Architect 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 PG75A1700023MR 630DMGMR3T 33-4-1252 312702MR3T 033-4-1005 518262MR750W To be provided 082427210212 To be provided 082427170026 To be provided GON4713311 To be provided M4017073 To be provided EM0601 To be provided O009MR03 To be provided GON4634845