Events

Recall of Device Recall BrightView XCT Gamma Camera, 3/8".

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
    59252
  • Event Risk Class
    Class 2
  • Event Number
    Z-2948-2011
  • Event Initiated Date
    2011-06-15
  • Event Date Posted
    2011-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102055
  • 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
    Single Phonton Emission Tomography (SPECT) System - Product Code KPS
  • Reason
    Non-conformances with brightview x/xct systems running version 2.0.1 including data transfer, xct acquisition, pixel mask for image reconstruction and table moving incorrectly.
  • Action
    Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers. The letter informed them of an upcoming software updated (version 2.5). For questions please contact 800-722-9377 (option 5).

Device

Device Recall BrightView XCT Gamma Camera, 3/8".
  • Model / Serial
    Model Number: 4535-604-262131. Catalog # 882482. Running system 2.0.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.
  • Product Description
    BrightView XCT Gamma Camera, 3/8". || Philips Medical Systems, Inc. || Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
  • 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