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 may 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. Prolonged periods of exposure to elevated acoustic noise could potentially lead to hearing impairment. Recall start date: October 31, 2024
RecallTracker