Reported Jan 13, 2016 · Terminated
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended…
Natus Neurology dba Excel Tech., Ltd. (XLTEK)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · 2568 Bristol Cir · Oakville, N/A · N/A
Is this the product you have?
- Natus Quantum System with NeuroWorks Software
- Catalog /Part Numbers013926. The Natus Quantum Amplifier is intended
- to be used as an electroencephalographto 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
- Lot codes and dates
- Serial Number
013926020008013926020009013926020006013926020016013926020014013926030024013926030031013926020001013926020004013926030059013926030060013926030074013926030075013926030052013926030017013926030018013926030021013926030053013926030101013926030058013926030019013926030038013926030039013926030044013926020015013926030097013926020013013926030055013926030056013926030081013926030096013926030078013926030048013926030057013926030064013926030047013926030027013926030025013926030042013926030023013926030030013926030036013926030026013926030050013926030080013926030099013926030035013926030046013926030049013926030073013926030020013926030092013926030040013926030041013926030061013926030062
- Serial Number
- Amount recalled
- 56 (43 US, 13 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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