Events

Recall of Brilliance 64 CT Model 728231

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
    74131
  • Event Risk Class
    Class 2
  • Event Number
    Z-2380-2016
  • Event Initiated Date
    2016-04-29
  • 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=146399
  • 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
    Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the philips brilliance 64 products that could affect the performance of the equipment.
  • Action
    The customers will be sent a letter with information about, what the problems are and under what circumstances they may occur, the actions customers can take to minimize the effect of the problem and the actions planned by Philips to correct the problem. To correct these issues, a Philips field service representative will install a software update on the affected systems. Reference field change order (FCO) 72800652.

Device

Brilliance 64 CT Model 728231
  • Model / Serial
    Model No. 728231, Brilliance 64 CT S/N: 9099,9134,9251,9515,9646,9822,9898,9983,10099,10180,10206,10208,91003,95130,95157,95387,95504,4001,9056,9074,9529  9538,9549,9554,9573,9574,9618,9625,9638,9653,9656, 9659,9667,9670,9686,9689,9703,9738,9740,9755,9782,9811, 9833,9837,9838,9859,9862,9901,9909,9910,9917,9920,9923,9927,9930,9933,9989,9993,10021,10024,10042,10047,10050,, 10051,10077,10092,10106,10150,10193,10213, 10250,10299,10379,10394,10422,10671,10698 29002,29014,29056,29107,29115,90124,90154,95022,95024,95191,95197,95222,95236,95258,95261,95351,95364,95399,95410,95475,95496,95507,95512,95524,95551,95563,95614,95616,  95668,95688,95691,95707,95811,95341A,9541,9548,9559,9561,9600,9631,9678,9711,9763,9805, 9890, 9922, 10012, 10014, 10179,10216,10302,10446,10470,10514,10610,10743,95239,95244,95343,95349,95374,95409,95439 95538, 300062,122921,123092,123096,123116,123117,29015,5169, 9367,9640,9997,123029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped to the following states: 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 CT Model 728231; To produce cross-sectional images of the body.
  • 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