Events

Recall of Device Recall Philips Allura Xper FD20 R8.2 722028

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    75845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0924-2017
  • Event Initiated Date
    2016-12-01
  • Event Date Posted
    2017-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151867
  • 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
    Due to a production error, screws were not tightened to specified torque. these screws may come loose from the c-arm shaft causing the c-arm to rotate uncontrolled.
  • Action
    Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.

Device

Device Recall Philips Allura Xper FD20 R8.2 722028
  • Model / Serial
    1000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: WA OUS: China, Spain, Korea, Republic of, Germany
  • Product Description
    Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA