Events

Recall of Device Recall DELTA XRF analyzer

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
    73251
  • Event Risk Class
    Class 2
  • Event Number
    Z-0803-2016
  • Event Initiated Date
    2016-01-13
  • 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=143625
  • 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
    The firm has discovered a software bug.
  • Action
    Olympus Scientific Solutions Americas ( OSSSA) planned action to bring product into compliance: Notification will be given to purchasers per 21 CFR 1003.21. A software modification will be made available to all users contacted. The letter to affected purchasers makes clear that the product will be brought into compliance without charge and offers the purchaser several options for applying the software update. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Tracking of customer/owner self-installation(s) of the software update should be done to the maximum possible extent via serial-number- controlled downloads, follow-up email reporting, return-mail card or some other similarly effective means. For further questions you may call : (866) 446-6689.

Device

Device Recall DELTA XRF analyzer
  • Model / Serial
    All models of the Delta XRF Analyzer
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution
  • Product Description
    Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical 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