Recall Z-0117-2016 ยท GWQ Full-Montage Standard Electroencephalograph
Natus Neurology Inc
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU
| Date | Oct 13, 2015 (initiated Sep 11, 2015) |
| Status | Terminated |
| Reason | When using the NicoletOne v5.94 software, after exiting the impedance check function and returning to the EEG screen, the impedance check signal remains active in waveform, obscuring the EEG signals. |
| Root cause | Software change control |
| Action | Natus Neurology sent an Ugent Medical Device Corrrection Notification letter dated September 9, 2015 to all affected consignees. The letter described the problem and the product involved in the recall. Consignees were informed consignees that a Field Service Technician will contact them to install the new software. Once the software is installed they will ask the Recipient or Field service Technician to complete and return the Verification Form. For questions regarding this recall call 608-829-8600. |
| Quantity | 101 (88 US, 13 OUS) |
| Distribution | Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964280 | DG NERVUS Medelec , Ltd., Jan 27, 1997 |