FDAMarch 5, 2020device

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

natus neurology dba excel tech ltd xlteknatusnatus neurology

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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