Events

Recall of Device Recall Xray Fluorescence

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
    76208
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-2017
  • Event Initiated Date
    2017-01-07
  • 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=152524
  • 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
    It was discovered under rare circumstances the led warning light circuit could fail. if this happens, while the instrument is emitting x-rays during at test, the led warning lights will not illuminate. the test runs normally and will execute as before, but the light will not be on.
  • Action
    Olympus will bring the defect compliance : 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 recall 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-tracked downloads, follow-up email reporting, return-mail card or by other similarly effective means. For further questions, please call (781) 419-3500.

Device

Device Recall Xray Fluorescence
  • Model / Serial
    affects all units.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
  • Product Description
    Olympus Scientific Solutions Americas Corporation || (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR || Analytical X-ray systems
  • 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