Events

Recall of Device Recall Philips Healthcare System Xray Tomography Computed

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
    75551
  • Event Risk Class
    Class 2
  • Event Number
    Z-0376-2017
  • Event Initiated Date
    2016-03-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150773
  • 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, tomography, computed - Product Code JAK
  • Reason
    It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during ct scans due to a potential mechanical linkage failure.
  • Action
    Philips planned action: 1. Philips issued a customer notification letter on October 13, 2016. The letter includes a statement that the corrections will be made free of charge. 2. Philips will initiate a field corrective action to address the issue. 3. Philips will contact the customer and schedule an inspection to determine if the unit requires repair. 4. If repair is required, the couch horizontal linkage assembly will be replaced. For further questions please call (978) 659-3000.

Device

Device Recall Philips Healthcare System Xray Tomography Computed
  • Model / Serial
    Ingenuity CT, Ingenuity Core, Ingenuity Core 128.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA(nationwide) Distribution to the states of : AZ, NY, GA, UT, TN, TX, AR, NV, Il, FL, MS, LA, MD, MO, MA, OK, KY, WY, SC, ND, NE, DE, MI, WA, CT, RI, KS, OR, IN, PA, CA, NJ, NC, MN, AL and IA.
  • Product Description
    Philips Healthcare System X-ray Tomography Computed :
  • 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