GE Medical Systems, LLC (GE HealthCare) has issued a recall for several magnetic resonance (MR) systems, including the SIGNA Architect, SIGNA Architect AIR, Discovery MR750w 3.0T, and SIGNA PET/MR models. The recall was initiated because the gradient coils in these systems can produce elevated acoustic noise during scanning that exceeds safety limits established by the International Electrotechnical Commission. This excessive noise can surpass 99 decibels even when patients are using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required by the system's manual. The manufacturer is notifying affected facilities to ensure corrective actions are taken to protect patient hearing.
Patients undergoing scans on these affected MR systems may be exposed to noise levels that exceed international safety standards, which can lead to hearing discomfort or potential hearing impairment despite the use of standard ear protection.
Recall #: Z-2130-2025
Recall #: Z-2131-2025
Recall #: Z-2132-2025
Recall #: Z-2133-2025
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.
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Sources: FDA iRES · Raw API Response
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