BEUDAMED
    FDA Recall Terminated

    natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

    Recall: Z-1630-2020 · Initiated March 5, 2020

    Recall

    Recall Number
    Z-1630-2020
    Event Number
    85189
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    FEI Number
    3002809369
    Product Code
    OMA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2020
    Posted
    April 1, 2020
    Terminated
    August 9, 2021
    Address
    2568 Bristol Cir, Oakville Canada

    Description

    natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

    Reason

    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.

    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.

    Distribution

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

    Quantity

    40 units