Events

Recall of Device Recall EasyDiagnost Eleva

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

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
    29470
  • Event Risk Class
    Class 2
  • Event Number
    Z-1306-04
  • Event Initiated Date
    2004-06-08
  • Event Date Posted
    2004-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33802
  • 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
    When reviewing images in the module before sending them to pacs or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
  • Action
    The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.

Device

Device Recall EasyDiagnost Eleva
  • Model / Serial
    The firm uses site numbers instead of serial numbers. 103164, 105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749, 505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015, 504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551, 505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522, 103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798, 105640, 105776, 506199, 504804, 504803.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Philips Medical Systems North American Company distributes product to medical facilities nationwide.
  • Product Description
    EasyDiagnost Eleva || Part Number 989605071921
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Hwy, Bothell WA 98021
  • Source
    USFDA