Z-1630-2020Class II

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

Name: Z-1630-2020 natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Creator: Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Published: 2020-03-05
License: https://open.fda.gov/license/

Natus Medical Incorporated / initiated 2020-03-05 / Terminated / root cause: manufacturing process

FDA source

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) began a recall of natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph on 2020-03-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1630-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-05
Posted: 2020-04-01
Terminated: 2021-08-09
Recalling firm: Natus Medical Incorporated
Product: natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Product code: OMA Amplitude-Integrated 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Natus initiated the recall by letter on 03/05/2020. the firm asked customers to return the affected units to Natus Medical Incorporated, 5900 First Avenue, Seattle, WA 98108, USA. Testing will be performed by Natus on the returned unit and will be returned to the consignee following completion of testing. Natus will provide a temporary replacement unit during this time.
Quantity in commerce: 40 units
Distribution: Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1630-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1630-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-04-01

Product code OMA

K123079Class IIOlympic Brainz MonitorExcel-Tech Ltd. (Xltek) / cleared 2013-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)