Natus Quantum System with NeuroWorks Software — Class II medical device recall Z-0581-2016
Terminated recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2016-01-13, distributed in AL, AR, AZ, CO, FL, GA, MA, MD…. During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Quantum hardwa
| Recall number | Z-0581-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, N/A, Canada |
| Recall initiated | 2015-11-11 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-10-03 |
| Distributed | AL, AR, AZ, CO, FL, GA, MA, MD, MN, MS, NJ, NY, OH, SC, TN, TX, UT |
| Countries outside the US | CA, CH, ES, GB, IN, KR, TH |
| UPC / GTIN / UDI-DI | 00013926020014, 00013926030020, 00013926030044, 00013926030075, 00013926030099 |
| Serial numbers | 013926020001, 013926020004, 013926020006, 013926020008, 013926020009, 013926020013, 013926020014, 013926020015, 013926020016, 013926030017, 013926030018, 013926030019, 013926030020, 013926030021, 013926030023, 013926030024, 013926030025, 013926030026, 013926030027, 013926030030, 013926030031, 013926030035, 013926030036, 013926030038, 013926030039 and 31 more |
| Model numbers | 013926 |
Product
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 polysomnographic (PSG) signals.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0581-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.