Events

Recall of Device Recall Philips Healthcare MD Eleva system

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
    61028
  • Event Risk Class
    Class 2
  • Event Number
    Z-1212-2012
  • Event Initiated Date
    2011-11-19
  • Event Date Posted
    2012-03-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107118
  • 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
    It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.
  • Action
    A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.

Device

Device Recall Philips Healthcare MD Eleva system
  • Model / Serial
    MultiDiagnost Eleva II - 708036, 708032,  MultiDiagnost Eleva FD - 708037, 708034,
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Philips Healthcare MD Eleva system. || Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional 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