Events

Recall of Device Recall Phillips Easy Diagnost Elva DRF

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
    64127
  • Event Risk Class
    Class 2
  • Event Number
    Z-0767-2013
  • Event Initiated Date
    2013-01-16
  • Event Date Posted
    2013-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115393
  • 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 mirror icon on the bottom of each image could be misinterpreted as a right lead marker for side indication if the image is mirrored within a pacs system.
  • Action
    Phillips issued an Urgent Field Safety Notice to all customers on January 14, 2013, to notify users that the Phillips EasyDiagnost Eleva systems, release 3.0 has a mirror icon that could be misinterpereted and could potentially lead to misdiagnosis. Philips will upgrade the system to version 3.1 which involves software and hardware upgrades of the system. This software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Additionally, Philips will provide updated Instructions for Use (IFU) for the Eleva workspot and the EasyDiagnost 3.1 system and an addendum to the EasyDiagnost system IFU. Users will be contacted by Phillips to schedule the installation. For questions contact your local Philips representative: 1-800-722-9377.

Device

Device Recall Phillips Easy Diagnost Elva DRF
  • Model / Serial
    Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including the states of FL, CA, WA, AZ, NC, KY, DE, AZ and MO.
  • Product Description
    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 || Product Usage: || Universal Fluoroscopic Applications
  • 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