BEUDAMED
    FDA Recall Open, Classified

    Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.

    Recall: Z-1991-2015 · Initiated June 9, 2015

    Recall

    Recall Number
    Z-1991-2015
    Event Number
    71649
    Firm
    Olympus Scientific Solutions Americas
    FEI Number
    3006241029
    Product Code
    RBS
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    June 9, 2015
    Posted
    July 31, 2015
    Address
    48 Woerd Ave, Waltham, MA, 02453-3824

    Description

    Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.

    Reason

    Higher than published scatter around the probe head when testing some samples. At the point the customer would interact directly with the instrument (Trigger position), most readings were lower. However, measurements around the probe head were higher particularly on samples know to be highly scattering (plastics, soils) with minimal increases on high density samples (steel, aluminum).

    Action

    Olympus Scientific Solutions planned action: 1. Notify product managers as to potential issues 2. Distribute new table and notice to instrument owners 30 JUL 15 3. Post new table on website for access 15 JUN 15

    Distribution

    Nationwide Distribution.

    Quantity

    1047