Events

Recall of Device Recall Philips Healthcare Brilliance 64

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
    75157
  • Event Risk Class
    Class 2
  • Event Number
    Z-0009-2017
  • Event Initiated Date
    2016-08-24
  • 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=149530
  • 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 infant performance test did not meet the test specification for the infant head uniformity test with high resolution. as a result, when the user performs high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as non-uniformity of the image, ct number shift greater than 5 hounsfield units, and reduction in gray/white matter differentiation. the issue is most sever in the high resolution mode, and the factory reference pediatric scan protocols are set to high resolution default. adults head scans have a factory reference protocol that defaults to standard resolution which doesn't experience the issue.
  • Action
    Philips sent an Urgent Field Safety Notice (FSN) CLE 16-045 letter dated August 26, 2016, via a certified letter to customers. The letter identified the affected product, problem, actions to be taken by customer/user and actions planned by Philips to correct the problem. The letter informed customers a Philips field service representative will install a software update on the affected systems. For questions 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, follow the prompts)..

Device

Device Recall Philips Healthcare Brilliance 64
  • Model / Serial
    4001, 4016, 5169, 9056, 9071, 9074, 9099, 9112, 9134, 9251, 9280, 9367, 9515, 9529, 9538, 9541, 9548, 9549, 9554, 9559, 9561, 9573, 9574, 9600, 9614, 9618, 9625, 9631, 9638, 9640, 9646, 9653, 9565, 9659, 9667, 9670, 9678, 9686, 9688, 9689, 9703, 9707, 9711, 9720, 9738, 9740, 9755, 9763, 9781, 9782, 9802, 9805, 9811, 9822, 9833, 9837, 9838, 9859, 9859, 9862, 9864, 9876, 9890, 9898, 9901, 9909, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9996, 9997, 9910, 9917, 9920, 9922, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 9993, 9997, 10012, 10014, 10021, 10024, 10032, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10179, 10180, 10193, 10206, 10207, 10208, 10213, 10216, 10221, 10250, 10255, 10299, 10302, 10379, 10394, 10422, 10446, 10470, 10473, 10503, 10514, 10605, 10610, 10671, 10698, 10743, 29002, 29005, 29014, 29015, 29049, 29056, 29057, 29107, 29115, 90098, 90106, 90124, 90131, 90154, 90205, 91003, 95022, 95024, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95239, 95244, 95258, 95261, 95341, 95343, 95345, 95351, 95364, 95374, 95387, 95399, 95409, 95410, 94539, 95441, 95475, 95496, 95504, 95507, 95512, 95524, 95538, 95551, 95563, 95614, 95616, 95656, 95668, 95688, 123029, 95691, 95707, 95811, 122921, 122921, 123092, 123096, 123116, 123117, 6003368, 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, GA, IA, IL, IN, FL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY. and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, COlumbia, Cuba, Denmark, Dijbouti, Dominican REpublic, Egypt, Estonia, Finland, France, Germany, Gilbraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Seitzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uniter Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
  • Product Description
    Brilliance 64 CT Model Number 728231 || Product Usage: || Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA