Events

Recall of Device Recall Philips Medical Systems FVRF (Clinix RF Plus)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) 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
    75994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1005-2017
  • Event Initiated Date
    2016-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151897
  • 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, stationary - Product Code KPR
  • Reason
    There's a potential for liquid penetration into the back side of the front control panel of the x-ray diagnostic table, which can cause a short circuit of the terminals of the tilt operation and cause an unintentional tilt of the table.
  • Action
    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated December 2, 2016 to customers via USPS certified letter with returned receipt. The letter identified the affected product, problem and actions to be taken. Additionally, your local Philips representative has been provided details regarding this Device Correction and can be contacted if you need any further information or support concerning this issue: Technical Support Line: 1-800-722-9377

Device

Device Recall Philips Medical Systems FVRF (Clinix RF Plus)
  • Model / Serial
    System Serial Numbers:  0162R15403 0162A66105 0162A65401 218134 217530 209677 716334 217721 0162R16001 0162A65301 0162R15803 0162R16002 209669 0162R15504 0162R15602 0162A66104 0162R16007 0162R15802 0162R15702 0162R16003 212866 218047 0162A66005 0162R15603 0162R16004 218085 0162R15804 217296 0162A65402 0162P21004
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the following states: AL, CA, FL, GA, HI, IL, IN, KS, LA, MA, MI, MS, NJ, NY, OH, PA, SC, VA, WI, WV, & WY.
  • Product Description
    FV-RF (Clinix RF Plus) || Product Usage: || A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various anatomical regions. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA