Events

Recall of Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)

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

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
    50748
  • Event Risk Class
    Class 2
  • Event Number
    Z-0623-2009
  • Event Initiated Date
    2008-12-30
  • Event Date Posted
    2009-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76931
  • 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
    Stationary X-Ray System - Product Code KPR
  • Reason
    System fails to meet requirements when it is used at kv levels greater than 115 kv at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
  • Action
    A Customer Notification letter describing the failure, the means, by which a customer can prevent the failure mode from occurring, and actions planned by Philips to correct the problem were sent to all users of the affected systems. Philips will modify the system software and will be installed at no cost to the customer.

Device

Device Recall MultiDiagnost Eleva with Flat Detector (MDE FD)
  • Model / Serial
    software version 4.3.1 or higher.  Units are identified with Site Numbers:  538440, 542581, 543228, 543846, 543886, 544123, 544124, 544904, 545113, 545114, 548112, 551714, 553435, 553838, 554283, 554284, 554633, 554640, 556369, 557258, 41445127, 41445131, 41445800, 41455927, 41643223, 41849575, 42549980, 42799914, and 41445927.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including states CA, CO, IA, ID, KS, MN, NC, NJ, NY, OH, SC, TX, UT, VA, and WI.
  • Product Description
    Philips Medical Systems MultiDiagnost Eleva Flat Detector System with software version 4.3.1 or higher || Used for general R/F, fluoroscopy, radiography, and angiography examinations.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA