GE Medical Systems is recalling approximately 16,035 units of various SIGNA and Discovery Magnetic Resonance (MR) imaging systems distributed worldwide. These medical devices have a software issue where the system's predicted energy levels can exceed safe limits when scanning in Low SAR Mode under specific imaging sequences. If you have an MR system including models like the SIGNA Architect, Pioneer, Artist, or Voyager, you should contact the manufacturer or your healthcare provider immediately to ensure safe operation. No specific remedy was provided in the initial notice, but professional technical support is required to adjust system configurations.
The software defect can cause the system to underestimate the amount of energy (radiofrequency) being delivered to a patient. If a patient has an MR-conditional implant, this error can lead to the implant overheating, potentially causing internal burns or tissue damage.
Technical Configuration Review and Manufacturer Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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