Agency classClass IIOur severity:High FDA (Devices)·Z-2476-2024·Announced 2024-08-14

GE SIGNA MR360 MRI System Software Defect May Overheat Implants

GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.

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 medical device recall with potential for serious harm (overheating of MR-conditional implants). No illnesses or injuries reported. Classified as High per rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Medical Systems has recalled certain SIGNA MR360 Nuclear Magnetic Resonance Imaging (MRI) systems due to a software defect. The affected systems have software versions SV25.5 or SV25.6, and 81 units worldwide are included in this recall.

The recalled systems can produce radiofrequency (RF) exposure levels that exceed the user-prescribed limit when operating in Low SAR Mode under specific conditions. The defect occurs when both 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's configuration.

If these conditions are met, the excessive RF exposure can cause overheating of MR-conditional medical implants in patients undergoing imaging scans.

This is an FDA Class II recall affecting healthcare facilities operating these specific MRI systems, particularly those scanning patients with MR-conditional implants.

The recalled product

Product: SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Diagnostic Imaging / MRI System
Hazard: device-malfunction
implant-overheating
rf-exposure
Affected units: 81

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: 082427110087
082427230163
082427160298
082427070229
082427100384
082427100377
082427120249
082427080097
082427130131
082427100383
082427100368
082427160308
082427120270
082427120268
082427150113
082427150115
082427010174
082427120282
082427120281
082427120255

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 →

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