BEUDAMED
    FDA Recall 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 · Initiated June 2, 2014

    Recall

    Recall Number
    Z-1990-2014
    Event Number
    68524
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2919016
    Product Code
    LRG
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 2, 2014
    Posted
    July 2, 2014
    Terminated
    December 23, 2015
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    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.

    Action

    Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.

    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.