GE Healthcare MRI Systems May Display Flipped Images Affecting Diagnosis
GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units 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: This is an FDA Class II recall for a medical device where the hazard—image inversion during diagnostic imaging—creates risk of diagnostic error and compromised patient care. No injuries or illnesses have been reported.
Plain-English summary
GE Healthcare, LLC has issued a recall for its 1.5T SIGNA Excite HD and 3.0T SIGNA Excite HD Magnetic Resonance Imaging (MRI) systems. The devices may display medical images with left-to-right inversion, altering image orientation from the intended display.
Inverted images in diagnostic imaging can affect clinical interpretation and diagnosis. Correct image orientation is critical for accurate identification of findings and appropriate patient care decisions.
The recall affects 76 units distributed worldwide, including the United States and numerous other countries and territories spanning North America, South America, Europe, Asia, Africa, the Middle East, and Oceania.
The recalled product
- Product
- 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Systems
- Hazard
- image-inversion
- misdiagnosis-risk
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: 928223MR3T
- 360397MR2
- 602406IMR
- 480323MR1
- 928SMIMR
- 3825
- 559325CIIMR1
- 805988MR2
- 6617263TMR
- 650306SMR3T
- 4036
- 3600
- 3266
- 818RIMR3T
- 4267
- 352333MR3T
- 407SOMR3T
- 941PCMR
- 386HPOMR
- ALLIANCESIG463
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