Events

Recall of Philips Healthcare DuraDiagnost Xray system

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
    74685
  • Event Risk Class
    Class 2
  • Event Number
    Z-2682-2016
  • Event Initiated Date
    2015-09-17
  • Event Date Posted
    2016-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148189
  • 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
    Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 cfr 1020.31(j), and the height-adjustable tabletop is missing the required labels [21 cfr 1010.2., 21 cfr 1010.3(a), and 21 cfr 1020.30(3)].
  • Action
    Philips plans to bring the products into compliance with the Federal standard at no cost to customers by implementing a field correction. 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will attach the warning label to maintain an audible volume, and issue a supplement to the user manual that instructs the user how to adjust the volume for the local noise environment and include a warning that the user shall maintain an audible volume. 3. You will attach the identification label to the affected Height-Adjustable Tabletop. 4. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. If you need any further information or support concerning this, please contact your local Philips representative or Philips Customer Service: 1-800-722-9377.

Device

Philips Healthcare DuraDiagnost Xray system
  • Model / Serial
    SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.
  • Product Description
    Philips DuraDiagnost stationary X-ray system
  • 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