FDA recall Z-1630-2020

Product

natus newborn care Olympic Brainz Monitor, REF OBM00002. 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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-03-05

Report date

2020-04-08

Termination date

2021-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oakville, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2020