Events

Recall of Device Recall Analytical XRay Fluorescence Systems of model family Delta

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Scientific Solutions Americas.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74593
  • Event Risk Class
    Class 2
  • Event Number
    Z-2255-2016
  • Event Initiated Date
    2016-06-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148001
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    X-ray fluorescence - Product Code RBY
  • Reason
    Trigger lock option does not always prevent x-ray generation. specifically if the unit is in test mode or repeat test mode then the trigger lock may not prevent x-ray initiation when the trigger is pulled. the correction is via repair by a software update.
  • Action
    The firm notified customers via an "Important - Electronic Product Radiation Warning" letter. It described the issue; and, told customers to not rely on the Trigger Lock feature until the software upgrade had been completed. The letter also provided instructions for customers to not only determine their software version; but, also instructions to bring their affected device into compliance. The firm will remedy the issue without charge. Customers can contact their local representative or OSSA at ani.technicalsupport@olympus-ossa.com, phone: +1 866 446 6689, fax: +1 781 419 3980, with questions or if additional information is needed.

Device

Device Recall Analytical XRay Fluorescence Systems of model family Delta
  • Model / Serial
    All Models of the Delta XRF Analyzer with Software version 2.5.17.1 and higher
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. || Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000, DS-4000, DS-6000, DS-6500, Delta, Delta 50, Delta Classic Plus, Delta Element, Delta Premium , Delta Professional , and Delta-Pl us.
  • Manufacturer
    Olympus Scientific Solutions Americas

Manufacturer

Olympus Scientific Solutions Americas
  • Manufacturer Address
    Olympus Scientific Solutions Americas, 48 Woerd Ave, Waltham MA 02453-3824
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA