Events

Recall of Digital Diagnost

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
    61528
  • Event Risk Class
    Class 2
  • Event Number
    Z-1464-2012
  • Event Initiated Date
    2012-04-03
  • Event Date Posted
    2012-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108354
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
  • Action
    The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.

Device

Digital Diagnost
  • Model / Serial
    Model #s 712020, 712022, 712082 All systems with Eleva software version 2.x and stitching option.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indonesia, Iran, Iraq, Italy, Japan, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Salkowski, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Ver.Arab.Emir.
  • Product Description
    Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option || Intended use: Stationary radiographic system, Radiographic system, digital
  • 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