FDA-Device2025-07-30Class II
SIGNA PET/MR
GE Medical Systems, LLC
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.
Sold states
Worldwide distribution - US Nationwide and the country of China.
Affected count
N/A
Manufactured in
3200 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
SIGNA PET/MR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2025Don't want to check this manually?
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