GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled
GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a risk-of-harm medical device (MRI systems) where injury has not yet been reported, fitting the High severity criterion for risk-of-harm products without confirmed injury. Although no deaths or serious injuries are documented, the potential for inaccurate diagnostic imaging due to improper software reinstallation warrants a High severity rating.
Plain-English summary
The U.S. Food and Drug Administration is recalling GE Healthcare MRI systems (Software Version 12.x) due to a software recall identified during service activities. The issue involves the possibility that the latest on-site software version was not reinstalled at some locations after service work was completed, which may result in images appearing flipped left/right and/or patient data becoming mismatched.
These MRI systems are used in healthcare facilities worldwide, including across all 50 U.S. states and numerous international countries. The recall affects approximately 5,200 total units distributed globally. While the recall addresses a software versioning problem rather than a direct physical malfunction, the potential for inaccurate diagnostic imaging represents a risk-of-harm scenario.
Consumers and healthcare providers should contact their facility management to confirm whether their specific MRI system is affected and follow any provided instructions regarding software updates or recalibration. Facilities should ensure proper reinstallation of the software version to restore correct imaging functionality and prevent potential patient care issues.
The recalled product
- Product
- GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5…
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — Medical Imaging
- Affected units
- 5,200
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)
- Model Number
- Serial Number (System ID) : 2226300
- 000000000R4938 (256329MR2)
- 2226300
- 000000000R5598 (256ALOPMR)
- N/A
- N/A (334699MR)
- 2377062-2
- 00000002547YR8 (256265HMR)
- 5107849
- 00000274691MR5 (205487MR2)
- 46-294231G1
- 0002005-0411-5 (870972E16)
- 002005-1201-35 (623583MR1)
- 00000963660YM6 (480323MR1)
- 5107849-2
- 00000278561MR6 (818445MR)
- 002004-1028-04 (3825)
- 2377062
- 00000941225YM5 (626335MR)
Distribution
Part of a larger recall action
This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · GE Medical Systems, LLC
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- HighGE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- HighGiraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
- HighGiraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateGE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version
FDA (Devices) · 2019-01-16
- HighGE Healthcare Recalls MRI Systems Due to Software Maintenance Issues
FDA (Devices) · 2015-04-01
- HighGE Healthcare MRI Systems Recalled Due to Potentially Flipped Images
FDA (Devices) · 2022-04-13
- ModerateGE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue
FDA (Devices) · 2013-05-08
- HighGE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk
FDA (Devices) · 2013-08-21
- ModerateGE Healthcare Recalls MRI Systems Due to Reporting Tool Error
FDA (Devices) · 2013-03-20