The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious.
The recall was initiated because a design flaw in the device may connect two separate electrode stimulation channels into one causing unwanted and higher than expected electrical stimulation, which may cause significant harm to a patient’s brain tissue.
The system is used to assist neurosurgeons in identifying brain structures during neurosurgery and to aid in the placement of depth electrodes for seizure monitoring.
Manufacturing and distribution dates were January 1, 2013, to January 9, 2018.
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