Natus Neurology DBA Excel Tech., Ltd. (XLTEK): Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalogr

Is my product affected?

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 /SleepW

• UPC 013926020008
• UPC 013926020009
• UPC 013926020006
• UPC 013926020016
• UPC 013926020014
• UPC 013926030024
• UPC 013926030031
• UPC 013926020001
• UPC 013926020004
• UPC 013926030059
• UPC 013926030060
• UPC 013926030074
• UPC 013926030075
• UPC 013926030052
• UPC 013926030017
• UPC 013926030018
• UPC 013926030021
• UPC 013926030053
• UPC 013926030101
• UPC 013926030058
• UPC 013926030019
• UPC 013926030038
• UPC 013926030039
• UPC 013926030044
• UPC 013926020015
• UPC 013926030097
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• UPC 013926030055
• UPC 013926030056
• UPC 013926030081
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• UPC 013926030047
• UPC 013926030027
• UPC 013926030025
• UPC 013926030042
• UPC 013926030023

Check against the official notice below — it lists the full affected range.

What happened

Natus Medical Incorporated has recalled 56 units of the Natus Quantum System with NeuroWorks Software (catalog/part number 013926) distributed worldwide, including to 16 U.S. states and 7 countries. The recall was initiated after internal testing identified that NeuroWorks 8.1 with Quantum hardware displays incoming signals with reversed polarity.

The record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: Worldwide Distribution: US Distribution including states of: AL, AZ, AR, CO, FL, GA, MD, MA, MN, MS, NJ, NY, OH, SC, TN, TX and UT; and countries of: INDIA, KOREA, SPAIN, SWITZERLAND, THAILAND, UNITED KINGDOM, and CANADA. . Quantity: 56 (43 US, 13 OUS) Lot/code info: Serial Number 013926020008 013926020009 013926020006 013926020016 013926020014 013926030024 013926030031 013926020001 013926020004 013926030059 013926030060 013926030074 013926030075 013926030052 013926030017 013926030018 013926030021 013926030053 013926030101 013926030058 013926030019 013926030038 013926030039 013926030044 013926020015 013926030097 013926020013 013926030055 013926030056 013926030081 013926030096 013926030078 013926030048 013926030057 013926030064 013926030047 013926030027 013926030025 013926030042 013926030023 013926030030 013926030036 013926030026 013926030050 013926030080 013926030099 013926030035 013926030046 013926030049 013926030073 013926030020 013926030092 013926030040 013926030041 013926030061 013926030062

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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