Events

Recall of Device Recall Easy Diagnost

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    61877
  • Event Risk Class
    Class 2
  • Event Number
    Z-1821-2012
  • Event Initiated Date
    2012-05-11
  • Event Date Posted
    2012-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109279
  • 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
    Table, radiographic, tilting - Product Code IXR
  • Reason
    If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. if, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. as a result of this, a surgical intervention may be execut.
  • Action
    Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.

Device

Device Recall Easy Diagnost
  • Model / Serial
    All systems with Eleva software version 4.x and stitching option.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    6 US customers
  • Product Description
    Philips Easy Diagnost || Product Usage: Stationary Fluoroscopic system
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA