Events

Recall of Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1

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
    71838
  • Event Risk Class
    Class 2
  • Event Number
    Z-2383-2015
  • Event Initiated Date
    2015-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139186
  • 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
    The system is designed to emit a beep upon termination of an exposure. however, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the microsoft windows 7 operating system.
  • Action
    Philips Healthcare sent an Urgent Field Safety Notice letter dated June 25, 2015 to customers. The letter identified the affected product, problem and actions to be taken. Philips plans to install a software upgrade in affected systems, which will eliminate this issue. Philips Healthcare Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your local philips representative.

Device

Device Recall Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1
  • Model / Serial
    DigitalDiagnost
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio. Internationally to Canada.
  • Product Description
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 || Product Usage: || The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
  • 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