Events

Recall of Device Recall Philips Brilliance CT 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
    66311
  • Event Risk Class
    Class 2
  • Event Number
    Z-0791-2014
  • Event Initiated Date
    2011-03-07
  • Event Date Posted
    2014-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122030
  • 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
    The doseright feature suggest a mas based on the measured patient size, a reference size and a reference mas. when scanning large children, the suggested mas may be higher than clinicians would expect.
  • Action
    Philips Medical Systems sent a Field Safety Notice letter dated February 25, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. Your Corrective Action Plan (CAP) is approved and consists of: 1. Notifying all affected users with Field Safety Notice 72800527/72800528 starting March 8, 2011. This Field Safety Notice has been reviewed and is approved. 2. Following up with all responses by dispatching a Field Service engineer to each site to install the software update at no cost to the user. 3. Tracking the responses from users by certified mail. For further questions please call (440) 483-7600.

Device

Device Recall Philips Brilliance CT system
  • Model / Serial
    Brilliance iCT: Model Number 728311 and 728306, Serial Number: 100103, 100019, 100023, 100170, 200047, 200013 200005 and 100087. Brilliance 64: Model Number 728231 and 728326, Seial Number: 4003, 9745, 9875, 90135, 90169, 95414, 300003, 300004, 300005 and 300010. Brilliance CT Big Bore, Model Number: 728243, Serial Number: 7006, 7060, 7154, 7298 and 7349.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of DC, IL, IN, MI, MO, NY, OH, OR, PA, TX and VT., and the countries of Australia, Belgium, China, Germany, India, Israel, Italy and The Netherlands.
  • Product Description
    Brilliance iCT, Brilliance 64 and Brilliance Big Bore || The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography 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 Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA