Recall Z-0946-2013 ยท GWL Amplifier, Physiological Signal
Natus Neurology Incorporated
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.
| Date | Mar 13, 2013 (initiated Feb 27, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Natus sent an "Urgent Medical Device Correction and Removal Notification' letter dated February 27, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter advised customers that a Natus Field Service technician will remove and replace the affected product at no charge to the users. The letter also advised if any of the affected products have been transferred to another location to please forward a copy of the letter and to notify Natus. For questions call 800-356-0007 ext. 5129. |
| Quantity | 114 (31 USA; 83 OUS) |
| Distribution | 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 S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103140 | NICOLET WIRELESS EEG Carefusion 209, Inc., Apr 8, 2011 |