Medical Device Recall: SIGNA Architect
GE Medical Systems, LLC · May 23, 2025
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the country of China.
States Affected
NATIONWIDE
Quantity Affected
N/A
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2130-2025
Status: ongoing
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