Events

Recall of Device Recall Brightview XCT, 3/4"

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

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
    58323
  • Event Risk Class
    Class 2
  • Event Number
    Z-2156-2011
  • Event Initiated Date
    2011-03-28
  • Event Date Posted
    2011-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98993
  • 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, tomography, computed, emission - Product Code KPS
  • Reason
    The current headholder to support bright view xct brain imaging allowed for imaging the brain but doe allow for imaging of the associated shoulder/neck area of the body.
  • Action
    Customer information sheets will be provided to all customers when the field change order commences in April 2011. Philips will implement a full change order for the installation of the new headholder to replace the old headholder, free of charge, to all affected Philips BrightView XCT SPECT/CT units. For questions regarding this recall call 408-463-3000.

Device

Device Recall Brightview XCT, 3/4"
  • Model / Serial
    Model number: 4535-604-62131: catalog number 882350; Serial number: 6340008.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indonesia, Malaysia, Taiwan, Germany, United Arab Emirates, Netherland, Switzerland, Ireland, Czech Republic and Canada.
  • Product Description
    Brightview XCT, 3/4" || Philips Medical Systems || Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA