Events

Recall of Device Recall Brilliance iCT CT XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

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
    59681
  • Event Risk Class
    Class 2
  • Event Number
    Z-3208-2011
  • Event Initiated Date
    2011-06-15
  • Event Date Posted
    2011-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103269
  • 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 errors. philips medical's field service engineers are installing software upgrades to certain of their brilliance ict and brilliance ict sp ct x-ray system units in order to correct non-conformances evidenced in these systems due to software errors.
  • Action
    Philips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action. For further questions please call (440) 483-7000.

Device

Device Recall Brilliance iCT CT XRay System
  • Model / Serial
    Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.
  • Product Description
    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. || The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA