Philips Medical Systems (Cleveland) Inc: 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

Recall number

Z-1351-2016

Recalling firm

Philips Medical Systems (Cleveland) Inc

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

Status

Terminated

Initiated

2016-02-05

Posted

not on file

Terminated

2018-07-02

Reason

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

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

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.

Lot, serial or model codes

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.

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

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

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