BEUDAMED
    FDA Enforcement Class II Terminated

    Aptio Automation Modules

    Recall: Z-0590-2017 · Reported November 23, 2016

    Enforcement

    Recall Number
    Z-0590-2017
    Event ID
    75417
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2016
    Initiation Date
    September 29, 2016
    Classification Date
    November 16, 2016
    Termination Date
    September 19, 2018
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Aptio Automation Modules

    Reason

    Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.

    Code Info

    "Refrigerated Storage Module (RSM): 10703049, 10715227, 10703036, 10713762, 10713767; "Centrifuge Module (CM): 10703032, 10713761, 10713764; "i2000SR Interface Module (i2000SR): 10989303, 10989304.

    Distribution

    Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam

    Quantity

    448 units