Events

Recall of Device Recall Philips Easy Diagnost Eleva DRF

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

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
    61365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1283-2012
  • Event Initiated Date
    2012-03-09
  • Event Date Posted
    2012-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107921
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Underexposed image due to lag in switching between auxiliaries.
  • Action
    Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.

Device

Device Recall Philips Easy Diagnost Eleva DRF
  • Model / Serial
    Software release 4.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
  • Product Description
    Philips Easy Diagnost Eleva DRF, Software release 4.0 || Fluoroscopic image-intensified Stationary X-Ray System.
  • Manufacturer
    Philips Medical Systems Gmbh, DMC

Manufacturer

Philips Medical Systems Gmbh, DMC
  • Manufacturer Address
    Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Roentgenstrasse 24, Hamburg Germany
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA