Events

Recall of Device Recall Brilliance 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
    59383
  • Event Risk Class
    Class 2
  • Event Number
    Z-3281-2011
  • Event Initiated Date
    2011-06-02
  • Event Date Posted
    2011-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102462
  • 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
    Component defect. philips medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the detector module system (dms) bolt on one (1) brilliance 64 ct x-ray unit. the firm initiated this action following philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the udms.
  • Action
    Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.

Device

Device Recall Brilliance CT XRay System
  • Model / Serial
    Model #78231, 510(k) #K03326, Serial Number: 9592.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including PA
  • Product Description
    Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. || The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device 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