Events

Recall of Philips Healthcare Ingenuity Core128

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
    74149
  • Event Risk Class
    Class 2
  • Event Number
    Z-1718-2016
  • Event Initiated Date
    2015-09-06
  • 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=146518
  • 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
    Software defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) doseright algorithm miscalculations leading to incorrect ctdi values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm.
  • Action
    Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 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, Option 5

Device

Philips Healthcare Ingenuity Core128
  • Model / Serial
    Software v. 4.13, 4.14 and 4.15.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
  • Product Description
    Philips Healthcare Ingenuity Core128 Computed Tomography 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