Events

Recall of Easy Diagnost Eleva

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, Inc..

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
    66705
  • Event Risk Class
    Class 2
  • Event Number
    Z-0431-2014
  • Event Initiated Date
    2013-10-30
  • Event Date Posted
    2013-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123097
  • 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
    System, x-ray, stationary - Product Code KPR
  • Reason
    The delivered application software was an outdated version to the model of equipment.
  • Action
    Philips Medical Systems sent an Urgent - Field Safety Notice dated October 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusromers were informed that the delivered application software was an outdated version to the model of their expipment and that a Philips Field Engineer will be implementing an upgrade of the application software. Customers were instructed to review the information contained in the letter with all memebers of their staff who need to be aware of its contents. Customers with questions were instructed to contact their Philips representataive: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.

Device

Easy Diagnost Eleva
  • Model / Serial
    706050, 706083, 706088
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MN, NH, DE, OR, MA, TX, OH, FL, CA, WA, and SC.
  • Product Description
    Easy Diagnost Eleva || Universal Fluoroscopic applications
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA