Events

Recall of Device Recall DuoDiagnost

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
    61007
  • Event Risk Class
    Class 2
  • Event Number
    Z-1220-2012
  • Event Initiated Date
    2011-12-26
  • Event Date Posted
    2012-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107027
  • 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
    The device is currently not compliant with fda's amended design criteria for this system, the product is not commercially available in the us. however, it was inadvertently shipped to puerto rico due to a logistical error.
  • Action
    Philips sent an Urgent - Field Safety Notice dated December 26, 2011 to the two affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter states that customers may continue to use the DuoDiagnost system until the new systems are replaced by Philips. A Philips representative will contact customers to arrange for the replacement of current system. For further information or support contact your local Philips representative.

Device

Device Recall DuoDiagnost
  • Model / Serial
    S/N: 07110582 and 09100826
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distributed in Puerto Rico
  • Product Description
    DuoDiagnost, model 707015, Universal RF system || Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and 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