BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-1991-2015
    Event ID
    71649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Scientific Solutions Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2015
    Initiation Date
    June 9, 2015
    Classification Date
    July 31, 2015
    Address
    48 Woerd Ave, N/A, Waltham, MA, 02453-3824, United States

    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).

    Code Info

    Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.

    Distribution

    Nationwide Distribution.

    Quantity

    1047