Events

Recall of Device Recall Olympus Scientific Solutions Americas 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
    71649
  • Event Risk Class
    Class 2
  • Event Number
    Z-1991-2015
  • Event Initiated Date
    2015-06-09
  • Event Date Posted
    2015-07-31
  • 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=138532
  • 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
    Industrial x-ray - Product Code RBS
  • 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

Device

Device Recall Olympus Scientific Solutions Americas Delta
  • Model / Serial
    Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product 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.
  • 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