Events

Recall of Device Recall BRILLIANCE VOLUME

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
    52214
  • Event Risk Class
    Class 2
  • Event Number
    Z-1582-2009
  • Event Initiated Date
    2008-12-22
  • Event Date Posted
    2009-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82541
  • 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 anomaly. an artifact may appear in brain scans and brain perfusion studies, when using 80kv and a ua, ub, or uc filter with this ct scanning device.
  • Action
    An "URGENT - Field Safety Notice" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an "URGENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.

Device

Device Recall BRILLIANCE VOLUME
  • Model / Serial
    Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
  • Product Description
    Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. || The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges 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