SIGNA PET/MR
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.
Worldwide distribution - US Nationwide and the country of China.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2025