NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either wi
FDA device recall Z-0117-2016 · posted 2015-10-13 · Terminated
Recall details
- Recalling firm
- Natus Neurology Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 101 (88 US, 13 OUS)
- Distribution
- Worldwide distribution. US nationwide, INDIA, ROMANIA, DENMARK, JAPAN, AUSTRALIA, RUSSIA, BANGLADESH, SRI LANKA, BRUNEI, and UNITED ARAB EMIRATES.
- Date initiated
- 2015-09-11
- Date posted
- 2015-10-13
- Date terminated
- 2016-03-08
- Location
- Middleton, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DG NERVUS (K964280) | Medelec , Ltd. | 1997-01-27 |