GE SIGNA Artist MR system may overheat implants in certain sequences
GE Medical Systems is recalling SIGNA Artist MR imaging systems because they may produce radiofrequency power exceeding user-set limits when using certain imaging sequences in Low SAR Mode, potentially causing MR-conditional implants to overheat.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential overheating of MR-conditional implants due to excessive radiofrequency power under specific imaging sequence conditions. Per the rubric, recalls with theoretical risks and no reported injury score at most 3 (High).
Plain-English summary
GE Medical Systems, LLC is recalling approximately 1,227 SIGNA Artist Nuclear Magnetic Resonance (MR) imaging systems with software versions DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, and MR30.1. These MR systems are used in healthcare facilities for diagnostic imaging procedures.
The recall was initiated because the system's predicted radiofrequency (B1+RMS) power output can exceed the limit that users set in Low SAR Mode under specific circumstances. Specifically, the issue occurs when 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 MR system configuration. When this occurs, excessive radiofrequency energy can be delivered, which may cause MR-conditional implants to overheat.
This issue potentially affects patients with MR-conditional implants (such as pacemakers, neurostimulators, or other metallic medical devices labeled as MR-compatible) who undergo imaging on these systems using the specified sequences with these settings. The affected systems have been distributed worldwide.
Healthcare facilities operating affected SIGNA Artist systems should contact GE Medical Systems for information regarding this issue. Facility staff should review their MR imaging protocols and be aware of this potential risk when using the specified T2 FLAIR sequences in Low SAR Mode.
The recalled product
- Product
- SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- rf-power-excessive
- implant-heating
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: 907ULMC3T
- 907264MR
- 907729ANMR
- 907580MR
- 907796JMR
- 907443MR
- 205SBMR
- 256ALIPM450
- 256ALOPMR
- 205934CVMR
- 205BVAMR2
- 205BVAMR1
- 205592MR4
- 205783MR3
- 256768MR450
- 205608MR
- 256265STMR
- 256SRIPM450
- 256CCIMR1
- 256HHMR3
Distribution
Distribution scope not specified by the agency.
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