GE Healthcare, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
GE Healthcare, LLC is recalling SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026