FDA Device recall Z-1630-2020
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph by Natus Neurology, citing 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 funct….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1630-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-05 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Natus Neurology |
| Distribution | US |
Product
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Reason
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.
Identifiers
| code_info | Serial Numbers: OBM00002G2119, OBM00002G2130, OBM00002G2131, OBM00002G2132, OBM00002G2133, OBM00002G2134, OBM00002G213…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2020%22
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