Events

Recall of Device Recall Philips Healthcare DigitalDiagnost

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

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
    74083
  • Event Risk Class
    Class 2
  • Event Number
    Z-1695-2016
  • Event Initiated Date
    2015-11-10
  • Event Date Posted
    2016-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146236
  • 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 detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the x-ray image.
  • Action
    Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.

Device

Device Recall Philips Healthcare DigitalDiagnost
  • Model / Serial
    software version - 4.0.4, 4.1.2, 4.1.3.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
  • Product Description
    Philips Healthcare DigitalDiagnost stationary X-ray system
  • Manufacturer
    Philips Healthcare

Manufacturer

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