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GE Medical Systems, LLC recalls SIGNA PET/MR
Recalled July 30, 2025 · FDA recall Z-2133-2025 · GE Medical Systems
Hazard
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual. · FDA Class II
Units
N/A
Sold at
Worldwide distribution - US Nationwide and the country of China.
Description
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Product
SIGNA PET/MR
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →