SIGNA UHP MRI System Software Versions May Cause Implant Overheating
GE Medical Systems is recalling SIGNA UHP MRI systems with software versions RX28.0 or MR30.1. A configuration issue can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants.
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 an FDA Class II medical device recall involving a software configuration issue that can cause radiofrequency output to exceed prescribed limits, potentially overheating MR conditional implants. The hazard represents a risk of harm to patients with implanted medical devices during specific imaging sequences.
Plain-English summary
GE Medical Systems, LLC is recalling the SIGNA UHP Nuclear Magnetic Resonance imaging system with affected software versions RX28.0 and MR30.1. A total of 6 units have been distributed worldwide for research use. The affected system IDs are: 650723PSYMR, 919684BIAC6, 919684MR5, 403944MR1, 082427040271, and 082427040289.
The system has a configuration issue where the predicted B1+RMS (radiofrequency) value can exceed the B1+RMS limit set by the user when scanning in Low SAR Mode with specific conditions: 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. When these conditions occur together, the system can cause overheating of an MR conditional implant.
Facilities operating affected SIGNA UHP systems should review their magnetic resonance imaging protocols and contact GE Medical Systems for guidance. Patients with MR conditional implants should inform their healthcare provider if they have previously undergone imaging on affected systems.
The recalled product
- Product
- SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- implant-overheating
- sar-limit-exceeded
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 (6)
- System ID: 650723PSYMR
- 919684BIAC6
- 919684MR5
- 403944MR1
- 082427040271
- 082427040289
Distribution
Distribution scope not specified by the agency.
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