Agency classClass IIOur severity:High FDA (Devices)·Z-2483-2024·Announced 2024-08-14

MRI System Software Error Can Overheat Patient Implants

GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is potential overheating of MR-conditional implants under specific imaging conditions; no actual harm has been documented. Theoretical harm to high-risk patients (implant recipients) without reported injury is classified as High per the rubric.

Plain-English summary

GE Medical Systems recalled three SIGNA 7.0T nuclear magnetic resonance imaging systems distributed worldwide (System IDs: 319335MR1, A204479601, MR00026). The affected software versions are 7T29.1 and MR30.1.

The systems have a software defect: under Low SAR Mode, when either a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence is selected AND the Optimized T2 FLAIR sequence option is turned off or not included in the system configuration, the predicted B1+RMS value can exceed the user-prescribed safety limit. This failure can result in overheating of MR-conditional implants placed in patients undergoing scanning.

Healthcare facilities with these affected MRI systems should contact GE Medical Systems for remediation guidance.

The recalled product

Product: SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI System
Hazard: implant-overheating
software-defect
Affected units: 3

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 (3)

System ID: 319335MR1
A204479601
MR00026

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 →

Same manufacturer · GE Medical Systems, LLC

See all →

High
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
High
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
High
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
High
Giraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
High
Giraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24

Same hazard · implant overheating