Z-1351-2016Class II

Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by...

Name: Z-1351-2016 Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-02-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-02-05 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data... on 2016-02-05. FDA classified it as Class II and gives the reason as "The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices". 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-1351-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-05
Posted: 2016-04-08
Terminated: 2018-07-02
Recalling firm: Philips North America LLC
Product: Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems sent a Customer Information dated February 5, 2016, to all affected customers via certified mail. The letter identified the product, the problem, and the action to be taken by the customer. To correct the issue Philips will release field change orders (FCO) 72800652 and 72800644 to install a software update on the affected systems. Customers with questions were instructed to contact their local Philips representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts). For questions regarding this recall call 440-483-2997.
Quantity in commerce: 285 units
Distribution: Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.
Product codes and lots: Model No. 728231; S/N: 1, 2, 4001, 9056, 9074, 9099, 9134, 9251, 9515, 9529, 9538, 9549, 9554, 9573, 9574, 9618, 9625, 9638, 9646, 9653, 9656, 9659, 9667, 9670, 9686, 9689, 9690, 9703, 9738, 9740, 9755, 9782, 9811, 9822, 9833, 9837, 9838, 9859, 9862, 9898, 9901, 9909, 9910, 9917, 9920, 9923, 9927, 9930, 9933, 9983, 9989, 9993, 10021, 10024, 10042, 10047, 10050, 10051, 10077, 10092, 10099, 10106, 10150, 10180, 10189, 10193, 10206, 10206, 10208, 10213, 10250, 10253, 10299, 10379, 10394, 10422, 10670, 10671, 10677, 10678, 10683, 10684, 10685, 10695, 10698, 10794, 10799, 10803, 29002, 29014, 29056, 29070, 29107, 29115, 90100, 90124, 90150, 90154, 91003, 95022, 95024, 95100, 95130, 95157, 95191, 95197, 95213, 95222, 95236, 95258, 95261, 95333, 95351, 95364, 95387, 95399, 95410, 95473, 95475, 95496, 95504, 95507, 95512, 95524, 95551, 95563, 95614, 95616, 95668, 95688, 95691, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95713, 95716, 95717, 95718, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95728, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95762, 95764, 95765, 95766, 95767, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95786, 95787, 95788, 95789, 95790, 95791, 95794, 95795, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95813, 95815, 95817, 95821, 95824, 95830, 95831, 95832, 95834, 95835, 95837, 95842, 95843, 95845, 95849, 95852, 95853, 95854, 95855, 95857, 95864, 95869, 95874, 95876, 95877, 95881, 95886, 95900, 95901, 95902, 95903, 95904, 95906, 95907, 95910, 95911, 95912, 95915, 95916, 95917, 95918, 95919, 95922, 95924, 95925, 95927, 95928, 95929, 95930, 95934, 95938, 95940, 95941, 95942, 95944, 95946, 95341A, 123002 & 123029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1352-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1353-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1354-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1355-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08
Z-1356-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-08

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)