FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Alpha Omega Initiates Recall of Neuro Omega System

May 9, 2019
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Alpha Omega pulled one lot of its Neuro Omega System, a device used to stimulate nerves and brain tissue and monitor, record and show bioelectric signals.

Alpha Omega said it issued the Class I recall because of risks related to improper cable connection, which could cause the device’s current to overcharge and cause tissue damage.

The company originally informed customers of the issue in September 2018.

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