GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk
GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.
What this means for you
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 a Class II medical device recall involving potential harm to patients with implanted devices. No injuries or illnesses have been reported, and the hazard is contingent on specific operating modes and imaging configurations, making it a risk-of-harm scenario without reported injury.
Plain-English summary
GE HealthCare has identified a potential radiofrequency power control issue in the Brivo MR355 magnetic resonance imaging (MRI) system. The affected systems run software versions SV20.3, SV23.3, MR30.0, or MR30.1.
The issue occurs in Low SAR Mode when both of the following conditions are present: the 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. Under these circumstances, the predicted B1+RMS (radiofrequency power) value can exceed the user-prescribed limit, which can result in overheating of MR-conditional implanted medical devices.
Approximately 375 units of the Brivo MR355 have been distributed worldwide. Healthcare facilities using these systems should review the recall information and determine whether corrective measures are needed based on their system configuration.
The recalled product
- Product
- Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- radiofrequency-exposure
- implant-overheating
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: MSF067-1-6AB94D05
- DZ1570MR01
- MRR9492
- MRR10103
- MRR10449
- MRR9613
- MRR9196
- MRR9924
- MRR9725
- MRR10479
- MRR9358
- MRR9372MM3
- MRR9496
- 083027600051013
- MRR8258
- MRR10217
- MRR8634
- MRR9104
- MRR10184
- MRR9949
Distribution
Distribution scope not specified by the agency.
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