BEUDAMED
    FDA Enforcement Class II Terminated

    natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph

    Recall: Z-1630-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1630-2020
    Event ID
    85189
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    March 5, 2020
    Classification Date
    April 1, 2020
    Termination Date
    August 9, 2021
    Address
    2568 Bristol Cir, N/A, Oakville, N/A, N/A, 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.

    Code Info

    Serial Numbers: OBM00002G2119, OBM00002G2130, OBM00002G2131, OBM00002G2132, OBM00002G2133, OBM00002G2134, OBM00002G2135, OBM00002G2136, OBM00002G2137, OBM00002G2138, OBM00002G2139, OBM00002G2140, OBM00002G2141, OBM00002G2142, OBM00002G2143, OBM00002G2144, OBM00002G2145, OBM00002G2146, OBM00002G2147, OBM00002G2148, OBM00002G2149, OBM00002G2150, OBM00002G2151, OBM00002G2152, OBM00002G2153, OBM00002G2154, OBM00002G2155, OBM00002G2156, OBM00002G2157, OBM00002G2158, OBM00002G2159, OBM00002G2160, OBM00002G2161, OBM00002G2162, OBM00002G2163, OBM00002G2164, OBM00002G2165, OBM00002G2166, OBM00002G2167, OBM00002G2168

    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