natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

FDA Device Recall #Z-1630-2020 — Class II — March 5, 2020

Recall Summary

Recall Number Z-1630-2020
Classification Class II — Moderate risk
Date Initiated March 5, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Location Oakville, N/A
Product Type Devices
Quantity 40 units

Product Description

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

Reason for Recall

The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.

Distribution Pattern

Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom

Lot / Code Information

Serial Numbers: OBM00002G2119, OBM00002G2130, OBM00002G2131, OBM00002G2132, OBM00002G2133, OBM00002G2134, OBM00002G2135, OBM00002G2136, OBM00002G2137, OBM00002G2138, OBM00002G2139, OBM00002G2140, OBM00002G2141, OBM00002G2142, OBM00002G2143, OBM00002G2144, OBM00002G2145, OBM00002G2146, OBM00002G2147, OBM00002G2148, OBM00002G2149, OBM00002G2150, OBM00002G2151, OBM00002G2152, OBM00002G2153, OBM00002G2154, OBM00002G2155, OBM00002G2156, OBM00002G2157, OBM00002G2158, OBM00002G2159, OBM00002G2160, OBM00002G2161, OBM00002G2162, OBM00002G2163, OBM00002G2164, OBM00002G2165, OBM00002G2166, OBM00002G2167, OBM00002G2168

Other Recalls from Natus Neurology DBA Excel Tech., Ltd....

Recall # Classification Product Date
Z-2138-2025 Class II Natus Brain Monitor Breakout Box, Part Number 0... Jun 18, 2025
Z-1925-2025 Class II Brand Name: OBM00002 OBM DAB (Digital Acquisiti... May 7, 2025
Z-0661-2022 Class II IPELA FHD PTZ TILE KITS with Axis cameras used ... Dec 2, 2021
Z-2737-2018 Class II Natus Neurology ErgoJust Carts labeled as the f... May 18, 2018
Z-2570-2018 Class II XLTEK EMU40EX EEG Headbox May 15, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.