Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

Recall date

March 5, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1630-2020

FDA classification

Class II

Brand / firm

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

Sold / distributed

Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph