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Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channe...

FDA Device Recall #Z-0946-2013 — Class II — February 27, 2013

Recall Summary

Recall Number Z-0946-2013
Classification Class II — Moderate risk
Date Initiated February 27, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Natus Neurology Incorporated
Location Middleton, WI
Product Type Devices
Quantity 114 (31 USA; 83 OUS)

Product Description

Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

Reason for Recall

Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.

Distribution Pattern

Worldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM

Lot / Code Information

C110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019 C110318006 C110318013 C110519022 C110519021 C110323024 C110323039 C110323037 C110323034 C110519003 C110323011 C110323007 C110815003 C110323040 C110815030 C110815015 C110517040 C110815026 C110519031 C110519030 C110513015 C110519035 C110318009 C110815020 C110519023 C110519023 C110815001 C110519010 C110519017 C110318018 61855 C110519002 C110323006 38249 C110815007 C110323036 C110519007 C110519012 C110519027 C110318008 C110318016 C110318026 C110318027 C110519008 C110519009 C110815023 C110815013 C110519034 C110519029 C110323050 C110118018 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C110318016 C110318002 C110815016 C110815012 RC110125M C110323018 C110815024 A4312 & A4314 C110318014 C110318011 C110318015 34902 C110815011 C110309001 C110519002 A42A0 C110318025 C110519036 C110519028 C110519024 C110519013 C110318005

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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