SIGNA Architect MRI System Software Can Exceed Implant Heating Limits
GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. While no illnesses or injuries have been reported, the potential hazard of overheating MR-conditional implants represents a significant risk-of-harm scenario, warranting a High severity score per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling certain SIGNA Architect MRI imaging systems due to a software issue that can cause radiofrequency (B1+) energy levels to exceed user-prescribed limits. The recall affects 834 units with software versions DV26.0-DV26.3, DV27.0-DV27.3, DV28.0-DV28.5, DV29.0-DV29.2, and MR30.0-MR30.1, distributed worldwide.
The issue occurs when scanning in Low SAR Mode while using 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences, particularly when the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration. Under these specific conditions, the system's predicted B1+RMS value can exceed the prescribed limit.
This condition can result in overheating of MR-conditional implants. Healthcare facilities operating affected systems should verify their software versions and be aware of the imaging sequence combinations that trigger this issue when scanning patients with MR-conditional implants.
The recalled product
- Product
- SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- implant-overheating
- mri-software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System ID: 907373MR
- 2058773T
- 251435MR3T
- 480507MR2
- 928475MR1
- SMITOMARC
- 928348MR
- 480425MR10
- 510SHARMR
- 310680DVMR
- 213825DVMR4
- 510HHARCMR
- SMCARC3TMR
- 510204ARMR
- 415723SHMR22
- 415723CHMR5
- 925734ARMR
- 650723NCMR3
- UCDACC3TMR
- 415CPCHMR1
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03