Agency classClass IIOur severity:High FDA (Devices)·Z-2471-2024·Announced 2024-08-14

GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode

GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.

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 affecting medical imaging systems with a software defect that can cause overheating of MR-conditional implants. Risk is limited to patients with implanted devices and specific imaging sequence configurations; no injuries have been reported.

Plain-English summary

GE Medical Systems recalled approximately 2,146 SIGNA 1.5T MR imaging systems distributed worldwide. These affected systems contain software versions HD16.0_V03 through HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, and MR30.1.

The defect affects the system's calculation of safe radiofrequency output levels. When the system operates in Low SAR mode with either 2D FSE T2 FLAIR or T2 FLAIR Propeller imaging sequences, and when the Optimized T2 FLAIR option is disabled or not included in the configuration, the system may deliver radiofrequency energy that exceeds safe limits.

The specific risk is to patients with MR-conditional implanted devices. Excessive radiofrequency exposure can cause these implants to overheat. No illnesses or injuries related to this defect have been reported.

The recalled product

Product: 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Magnetic Resonance Imaging System
Hazard: overheating
implant-risk
Affected units: 2,146

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: 907373VMR
256SPMR2
870642MR
5340995MR11
KRMCMR2
SMSCIA2
714229MR2
SHIMR02637
310358VMR
RADNETMR664
559447MRVOYA3
559447MRVOYA2
559447MRVOYA1
INSIGHTMR1397
626359VMR4
INSIGHTMR1371
ALLIANCEVOYA04
707431MR
323294VMR
310823VMR

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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