Events

Recall of Device Recall Digital Diagnost 3.1.x. 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
    77312
  • Event Risk Class
    Class 2
  • Event Number
    Z-2154-2017
  • Event Initiated Date
    2017-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155677
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    During recent evaluations of the philips digitaldiagnost 3.1.X, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
  • Action
    Philip's planned action to bring defect into compliance: 1. You will contact customers and initiate a software update to correct the issue that incorrectly notifies the user of the detectors being ready. 2. You will install the software/firmware and perform testing to ensure the software update was effective. 3.You will provide a customer notification letter that includes a statement that you will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2.Philips Healthcare will implement this CAP by November 10, 2017. If you need any further information or support concerning this Issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.

Device

Device Recall Digital Diagnost 3.1.x. XRay system
  • Model / Serial
    DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
  • Product Description
    Philips DigitalDiagnost 3.1.x 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