Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. Recalled by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Due to During an internal testing, Natus Medical Incorporated, identified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Natus Neurology DBA Excel Tech., Ltd. (XLTEK) directly.
Affected Products
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
Quantity: 56 (43 US, 13 OUS)
Why Was This Recalled?
During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardware, the incoming signal is displayed with reversed polarity.
Where Was This Sold?
This product was distributed to 17 states: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX, UT
About Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report