Reported Apr 8, 2020 · Terminated

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

Natus Neurology dba Excel Tech., Ltd. (XLTEK)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Natus Neurology DBA Excel Tech., Ltd. (XLTEK) · 2568 Bristol Cir · Oakville, N/A · N/A

Is this the product you have?

  • natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Lot codes and dates
  • 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
Amount recalled
40 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 9, 2021 · Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.