Food, drugs, devices › Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Device recall: Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
FDA enforcement event 97091 is a device recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK) of Oakville, N/A, initiated 18 Jun 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Natus Neurology DBA Excel Tech., Ltd. (XLTEK) has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Natus Neurology DBA Excel Tech., Ltd. (XLTEK), Oakville, N/A, Canada.
Reason for recall
"Natus received two complaints of left side labeling show impedance for right side."
Distribution
"US: CA, IN, MO, NC, PA, RI, TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2138-2025 | Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph | 27 units | Class II | Ongoing | 30 Jul 2025 |
Context
Other enforcement events for Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 May 2025 | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Ca | Device | Class II | 1 |
| 2 Dec 2021 | IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software | Device | Class II | 1 |
| 5 Mar 2020 | natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph | Device | Class II | 1 |
| 18 May 2018 | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Ext | Device | Class II | 1 |
| 15 May 2018 | XLTEK EMU40EX EEG Headbox | Device | Class II | 1 |
| 11 Nov 2015 | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to | Device | Class II | 1 |
All 7 events for Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Natus received two complaints of left side labeling show impedance for right side."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: CA, IN, MO, NC, PA, RI, TX"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.