Events

Recall of Device Recall Philips MultiDiagnost Eleva IITV

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
    60898
  • Event Risk Class
    Class 2
  • Event Number
    Z-0985-2012
  • Event Initiated Date
    2012-01-09
  • Event Date Posted
    2012-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106736
  • 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, angiographic - Product Code IZI
  • Reason
    Incorrect skin dose calculation. akr (air kerma rate) displayed and stored in patient records is too low.
  • Action
    Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Use. For further information or support concerning this issue contact your local Philips representative at 866-767-2822.

Device

Device Recall Philips MultiDiagnost Eleva IITV
  • Model / Serial
    Software Release: PBL 6.1.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK
  • Product Description
    MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 || Product Code 708036 || Product Usage: || The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
  • 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