BEUDAMED
    FDA Enforcement Class II Terminated

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    Recall: Z-1990-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1990-2014
    Event ID
    68524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    June 2, 2014
    Classification Date
    July 2, 2014
    Termination Date
    December 23, 2015
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427, United States

    Description

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    Reason

    Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.

    Code Info

    WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.

    Quantity

    WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.