Events

Recall of Brilliance 64 Computed Tomography Xray Systems,

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
    73961
  • Event Risk Class
    Class 2
  • Event Number
    Z-1872-2016
  • Event Initiated Date
    2016-04-08
  • 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=145692
  • 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
    The firm became aware of a problem where the system may not map varian drive after ct user logout/login.
  • Action
    The firm sent a Customer Information letters dated March 8, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).

Device

Brilliance 64 Computed Tomography Xray Systems,
  • Model / Serial
    Model No. 728231; S/N: 4001 5169 9056 9074 9099 9134 9251 9515 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9600 9618 9625 9631 9638 9646 9653 9656 9659 9667 9670 9678 9686 9689 9703 9711 9738 9740 9755 9763 9782 9805 9811 9822 9833 9837 9838 9859 9862 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9983 9989 9993 10012 10014 10021 10024 10042 10047 10050 10051 10077 10092 10099 10106 10150 10179 10180 10193 10206 10208 10213 10216 10250 10299 10302 10379 10394 10422 10446 10470 10514 10610 10671 10698 10743 29002 29014 29015 29056 29107 29115 90124 90154 91003 95022 95024 95130 95157 95191 95197 95213 95222 95236 95239 95244 95258 95261 95343 95349 95351 95364 95374 95387 95399 95409 95410 95439 95475 95496 95504 95507 95512 95524 95538 95551 95563 95614 95616 95668 95688 95691 95707 95811 122856 122863 122866 122877 122902 122921 122922 122953 123070 123092 123096 123116 123117 300062 95341A
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
  • Product Description
    Brilliance 64 Computed Tomography X-ray Systems || Product Usage: || Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • 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