Events

Recall of Device Recall Philips Medical Systems Allura Xper FD20C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, 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
    68723
  • Event Risk Class
    Class 2
  • Event Number
    Z-0182-2015
  • Event Initiated Date
    2014-07-08
  • Event Date Posted
    2014-11-07
  • 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=128568
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Faulty automatic motion controller (amc), a problem in the power on self test (post) error handling was detected, can result in a hazardous movement of the c-arc. system.
  • Action
    Philips Medical Systems issued certified letters on 7/8/14 and receipt returned for tracking purposes. A mandatory Field Change Order with reference FC072200253 is being released that requires Philips field service engineers to install Software release R8.2.0.3. If you need any further information or support concerning this issue, contact your local Philips representative: SUPPORT 1-800-722-9377.

Device

Device Recall Philips Medical Systems Allura Xper FD20C
  • Model / Serial
    Allura Xper Software version R8.2.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
  • Product Description
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O || System Code: 722035. || The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA