FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
- Recall number
- Z-2380-2016
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
- Status
- Terminated
- Initiated
- 2016-04-29
- Posted
- not on file
- Terminated
- 2018-07-02
- 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.
- Root cause
- Software design
- 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.
- Quantity
- 150
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K033326"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28