Events

Recall of Philips Healthcare Practix Convenio

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
    61830
  • Event Risk Class
    Class 2
  • Event Number
    Z-1538-2012
  • Event Initiated Date
    2011-10-19
  • Event Date Posted
    2012-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109197
  • 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, mobile - Product Code IZL
  • Reason
    When the system is switched off or when the tube arm is parked in the down position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 pgy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (x-ray generator switch off), a radiation pulse (50 kv, 2.5 pgy) is generated inadvertently. the failure happened when component supplie.
  • Action
    Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501.

Device

Philips Healthcare Practix Convenio
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Philips Healthcare Practix Convenio Mobile X-ray system || Worldwide Distribution -- Nationwide
  • 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