Recall Z-0581-2016 ยท GWQ Full-Montage Standard Electroencephalograph
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 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 po
| Date | Nov 11, 2015 |
| Status | Terminated |
| 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. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | The firm, Natus Neurology, sent an "Urgent Medical Device Correction Notification" letter on 11/11/2015. The letter described the the problem, the product involved in the recall and actions to be taken. Natus will provide further information once an updated software is released. The consignees were instructed to complete and return the confirmation form by mail to Senior Manager Quality and Regulatory Affairs, Excel-Tech, Ltd (XLTEK) Division, Natus Medical Incorporated, 2568 Bristol Circle, Oakville, ON L6H 5S1 or by email to :ots@natus.com. If you have any questions, contact Senior Manager |
| Quantity | 56 (43 US, 13 OUS) |
| 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. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143440 | Natus Quantum Natus Medical Incorporated, Apr 20, 2015 |