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Terminated

natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

FDA Recall Z-1630-2020 · Posted 2020-04-01

Recalling FirmNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
Recall StatusTerminated
Product CodeOMA
Date Initiated2020-03-05
Date Terminated2021-08-09
Product Quantity40 units

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.

Firm Action

Natus initiated the recall by letter on 03/05/2020. the firm asked customers to return the affected units to Natus Medical Incorporated, 5900 First Avenue, Seattle, WA 98108, USA. Testing will be performed by Natus on the returned unit and will be returned to the consignee following completion of testing. Natus will provide a temporary replacement unit during this time.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123079OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek) · 2013-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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