Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
This recall has been terminated (originally issued April 29, 2016).
- Recall Initiated
- April 29, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-2380-2016
- Quantity
- 150
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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.