Recall Z-0581-2016— Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Class II · Terminated
Class II FDA medical device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), initiated 2015-11-11, terminated 2016-10-03. It names one FDA 510(k) clearance: K143440. Product: 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.. Reason: 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..
- Recalling firm
- Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-11
- Terminated
- 2016-10-03
- Firm location
- Oakville, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.