Z-2380-2016Class II

Brilliance 64 CT Model 728231; To produce cross-sectional images of the body

Name: Z-2380-2016 Brilliance 64 CT Model 728231; To produce cross-sectional images of the body
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-04-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-04-29 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 CT Model 728231; To produce cross-sectional images of the body on 2016-04-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2380-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-29
Posted: 2016-08-10
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2380-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2380-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10
Z-2381-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10
Z-2382-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10
Z-2383-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10
Z-2384-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10
Z-2385-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-10

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)