FDA (Devices) recall action 97030
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
GE HealthCare SIGNA Architect MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.