GE SIGNA Excite 3T MRI Systems Recalled Over Potential Image Flip
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
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: Although this is an FDA Class II device with no reported injuries or deaths, the potential for systematically flipped diagnostic images represents a risk-of-harm product where image distortion could lead to misdiagnosis and inappropriate clinical decisions, meeting the criteria for High severity.
Plain-English summary
GE Healthcare, LLC is recalling the SIGNA Excite 3T Magnetic Resonance Imaging (MRI) System. The recall affects 55 units distributed across the United States and approximately 50 additional countries worldwide, including Canada, Australia, Japan, Germany, France, United Kingdom, and others.
The systems may produce diagnostic images that are flipped horizontally (left to right). This image orientation error could compromise diagnostic accuracy and lead to misinterpretation of medical images, potentially affecting clinical decision-making and patient management.
Healthcare facilities operating these MRI systems should immediately assess the correct image orientation and verify whether any diagnostic images produced by the affected units may have been compromised. Patients who received MRI imaging from affected systems should consult their healthcare providers to determine if additional evaluation or imaging is needed.
For technical assistance or recall information, affected facilities should contact GE Healthcare, LLC. The complete list of affected system IDs and additional details are available through the FDA recall database.
The recalled product
- Product
- SIGNA Excite 3T. Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- image-flip
- diagnostic-error
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 IDs: 3422
- 209577MRMOBX
- 407303CHMR
- SIMONVILLAGES3T
- 321MR3T3
- 321MR3T2
- 407999MR3T
- 316268TWIN3
- 8109873T
- 732473MR
- 702433SIM3T
- 864573MBMR2
- 901726OPMR
- 214879INVIVO
- 817578LGMR2
- 972665XDDAMR1 2284SIG15T
- 47413
- 2550000
- 975
- 604270MR3T
Distribution
Distributed nationwide across the United States.
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