MRI System Software Error Can Cause Implant Overheating in Low SAR Mode
GE HealthCare's Discovery MR950 MRI system may incorrectly calculate heating safety limits when using certain imaging sequences in Low SAR Mode, potentially causing overheating of MR-conditional implants.
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: This is an FDA Class II recall involving a software error that creates a risk of overheating in MR-conditional implants. No hospitalizations or injuries have been reported in the source, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE HealthCare has issued a recall for the Discovery MR950 Nuclear Magnetic Resonance (MRI) imaging system running software version 7T23.0, used for research purposes. The system is identified as System ID: EX0001.
The system's software contains a calculation error in the predicted B1+RMS value, which measures radiofrequency heating safety limits. Under specific conditions—when the system operates in Low SAR Mode while using either 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences with the Optimized T2 FLAIR option turned off or not included—the predicted heating value can exceed the user-prescribed limit. This error can result in overheating of MR-conditional implants during patient scanning.
Affected users should contact GE HealthCare for software updates or corrective measures. Facilities using this system should restrict the identified imaging sequences, ensure the Optimized T2 FLAIR option is enabled, or implement other mitigation measures provided by GE HealthCare until a permanent fix is available.
The recalled product
- Product
- Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
- Manufacturer
- GE Medical Systems, LLC
- Affected units
- 1
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 (1)
- System ID: EX0001
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 26 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 26 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 malfunction
See all →- HighPhilips PIC iX Essentials Patient Information System Software Recall
FDA (Devices) · 2026-09-23
- HighPhilips Patient Information Center iX Software Malfunction Recall
FDA (Devices) · 2026-09-23
- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
Similar recalls
- HighGE Healthcare MRI system recalled for RF energy safety control failure
FDA (Devices) · 2025-03-05
- HighMRI System Software May Fail to Warn of Inadequate Ventilation
FDA (Devices) · 2024-05-22
- HighMRI Systems Allow Unsafe Scan Resumption Exceeding SAR Safety Limits
FDA (Devices) · 2025-03-05
- HighMRI Systems May Resume Scans When SAR Exceeds Safe Limits
FDA (Devices) · 2025-03-05
- SevereGE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk
FDA (Devices) · 2017-02-22
- HighGE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption
FDA (Devices) · 2025-03-05