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Natus Neurology DBA Excel Tech., Ltd. (XLTEK) recalls natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Recalled April 8, 2020 · FDA recall Z-1630-2020 · Natus Neurology
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. · FDA Class II
Units
40 units
Sold at
Worldwide distribution. US nationwide, Australia, Dominican Republic, United Arab Emirates, Israel, Italy, Hong Kong, Korea, Hungary, Switzerland, Colombia, and United Kingdom
Description
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.
Product
natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph
Manufacturer(s)
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →