Events

Recall of Device Recall BrightView X upgrade to XCT

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
    76183
  • Event Risk Class
    Class 2
  • Event Number
    Z-1187-2017
  • Event Initiated Date
    2016-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152484
  • 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 intended use listed in the english and localized language ifus for brightview xct systems did not match the intended use documented in the 510k submission.
  • Action
    All customers were notified via certified mail with return receipt. International customers were notivied via Philips employees. A field change order was initiated. Non-responders will be followed up on. Lastly, effectivenss checks will be conducted.

Device

Device Recall BrightView X upgrade to XCT
  • Model / Serial
    Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
  • Product Description
    BrightView X upgraded to XCT 882454
  • 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