natus newborn care Olympic Brainz Monitor — Class II medical device recall Z-1630-2020
Terminated recall by Natus Neurology DBA Excel Tech., Ltd. (XLTEK), reported 2020-04-08, distributed nationwide. The OBM system functional test (impedance and noise) was not carried out on the affected items prior to releas
| Recall number | Z-1630-2020 |
|---|---|
| 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 | 2020-03-05 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, CO, DO, GB, HK, HU, IL, IT, KR |
| Quantity | 40 units |
| 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 and 15 more |
| Model numbers | OBM00002 |
Product
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.
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-1630-2020. 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.