Agency classClass IIOur severity:High FDA (Devices)·Z-2480-2024·Announced 2024-08-14

MRI System Software Issue Can Overheat Implanted Medical Devices

GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

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 device recall involving potential thermal injury to implanted medical devices. The source reports no injuries, illnesses, or deaths. Per the rubric, this qualifies as High (Score 3) because it represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

GE HealthCare recalled 23 SIGNA Victor MRI systems with software version MR30.1, which were distributed worldwide.

The systems have a software defect affecting how radiofrequency energy is calculated and limited. Under specific conditions—when the system operates in Low SAR Mode with a 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequence AND the Optimized T2 FLAIR sequence option is disabled or absent—the predicted B1+RMS radiofrequency energy value can exceed the user-prescribed safety limit. This can result in overheating of MR conditional implants, which are surgically implanted medical devices with specific MRI compatibility restrictions.

Patients with MR conditional implants who undergo MRI scans on the affected systems may be at risk if the system settings match the problematic combination described in the recall.

The recalled product

Product: SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI Imaging System
Hazard: implant-overheating
radiofrequency-hazard
Affected units: 23

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 ID: GON5374156
DZ4952MR01
MRPM1180
MRR8022
MRPM0474A
MRPM1267
MRR8322
MRPM0795
MRPM1093
FI1271MR01
XM9192701
MR53305381
397480MR01
PC7479MR04
H6383MR02
MR00226
MR00207
1553MR0071
PPS79502
SA2215MR01

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

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