Class 2 Device Recall Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanner

• Date Initiated by Firm: April 15, 2013
• Date Posted: July 02, 2013
• Recall Status: Terminated on January 12, 2015
• Recall Number: Z-1646-2013
• Recall Event ID: 65139
• 510(K)Number: K033326
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Computed Tomography X-ray systems ; ; Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
• Code Information: The following system code numbers and associated serial numbers are affected by this recall: System Code #728231, Serial #: 4001, 4003, 4016, 4020, 9009, 9029, 9030, 9033, 9034, 9037, 9038, 9040, 9041, 9043, 9044, 9045, 9048, 9049, 9051, 9052, 9054, 9056, 9058, 9059, 9062, 9063, 9064, 9065, 9066, 9067, 9068, 9069, 9070, 9071, 9072, 9073, 9074, 9075, 9077, 9080, 9081, 9083, 9086, 9087, 9088, 9089, 9092, 9093, 9094, 9096, 9098, 9099, 9104, 9105, 9106, 9107, 9108, 9112, 9118, 9120, 9126, 9127, 9131, 9135, 9137, 9138, 9140, 9142, 9143, 9148, 9151, 9156, 9159, 9160, 9162, 9163, 9166, 9171, 9172, 9173, 9175, 9177, 9180, 9187, 9190, 9195, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9213, 9214, 9215, 9216, 9217, 9218, 9235, 9243, 9259, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542, 9543, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 9612, 9613, 9614, 9615, 9616, 9617, 9618, 9619, 9620, 9621, 9622, 9623, 9624, 9625, 9626, 9627, 9628, 9629, 9630, 9631, 9632, 9633, 9634, 9635, 9636, 9637, 9638, 9639, 9640, 9641, 9642, 9643, 9644, 9645, 9646, 9647, 9648, 9649, 9650, 9651, 9652, 9653, 9654, 9655, 9656, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9670, 9671, 9672, 9673, 9674, 9675, 9676, 9677, 9678, 9679, 9680, 9681, 9682, 9683, 9684, 9685, 9686, 9687, 9688, 9689, 9690, 9691, 9692, 9693, 9694, 9695, 9697, 9698, 9699, 9700, 9701, 9702, 9703, 9704, 9705, 9706, 9707, 9708, 9709, 9710, 9711, 9712, 9713, 9714, 9715, 9716, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9731, 9732, 9734, 9735, 9736, 9737, 9738, 9739, 9740, 9741, 9742, 9743, 9744, 9745, 9746, 9747, 9748, 9749, 9750, 9751, 9752, 9753, 9754, 9755, 9756, 9757, 9758, 9759, 9760, 9761, 9762, 9763, 9764, 9765, 9766, 9767, 9768, 9769, 9770, 9771, 9772, 9773, 9774, 9775, 9776, 9777, 9778, 9779, 9780, 9781, 9782, 9783, 9784, 9785, 9786, 9787, 9788, 9789, 9790, 9791, 9792, 9793, 9794, 9795, 9796, 9797, 9798, 9799, 9800, 9801, 9802, 9803, 9804, 9805, 9806, 9807, 9808, 9809, 9810, 9811, 9812, 9813, 9814, 9815, 9816, 9817, 9818, 9819, 9820, 9821, 9822, 9823, 9824, 9825, 9826, 9827, 9829, 9830, 9831, 9832, 9833, 9834, 9835, 9836, 9837, 9838, 9839, 9840, 9841, 9842, 9843, 9844, 9845, 9846, 9847, 9848, 9849, 9850, 9852, 9853, 9854, 9855, 9856, 9857, 9858, 9859, 9860, 9861, 9862, 9863, 9864, 9865, 9866, 9867, 9868, 9869, 9870, 9871, 9872, 9873, 9874, 9875, 9876, 9877, 9878, 9879, 9880, 9881, 9882, 9883, 9884, 9885, 9886, 9887, 9888, 9889, 9890, 9891, 9892, 9893, 9894, 9895, 9896, 9898, 9899, 9900, 9901, 9902, 9903, 9904, 9905, 9906, 9907, 9908, 9909, 9910, 9911, 9912, 9913, 9914, 9915, 9916, 9917, 9918, 9919, 9920, 9921, 9922, 9923, 9924, 9925, 9926, 9927, 9929, 9930, 9931, 9933, 9936, 9937, 9938, 9940, 9941, 9942, 9946, 9947, 9948, 9950, 9951, 9952, 9953, 9954, 9956, 9957, 9958, 9959, 9960, 9961, 9963, 9964, 9965, 9966, 9968, 9969, 9970, 9971, 9972, 9974, 9975, 9976, 9978, 9980, 9981, 9982, 9983, 9984, 9985, 9986, 9987, 9989, 9991, 9993, 9994, 9995, 9996, 9997, 9998, 9999, 10000, 10001, 10002, 10003, 10004, 10005, 10006, 10007, 10008, 10009, 10011, 10012, 10014, 10015, 10016, 10017, 10018, 10019, 10020, 10021, 10022, 10023, 10024, 10025, 10026, 10027, 10028, 10030, 10031, 10032, 10033, 10034, 10035, 10036, 10037, 10039, 10040, 10041, 10042, 10044, 10045, 10046, 10047, 10048, 10049, 10050, 10051, 10052, 10053, 10054, 10056, 10057, 10058, 10059, 10060, 10061, 10064, 10065, 10066, 10067, 10068, 10069, 10070, 10071, 10072, 10073, 10075, 10077, 10078, 10079, 10080, 10081, 10083, 10084, 10085, 10086, 10087, 10088, 10089, 10090, 10092, 10094, 10095, 10096, 10097, 10098, 10099, 10100, 10101, 10102, 10103, 10104, 10105, 10106, 10107, 10108, 10109, 10110, 10111, 10112, 10113, 10114, 10115, 10116, 10117, 10118, 10119, 10120, 10121, 10122, 10123, 10124, 10125, 10126, 10127, 10128, 10129, 10130, 10131, 10132, 10134, 10135, 10136, 10137, 10138, 10139, 10140, 10141, 10142, 10143, 10144, 10145, 10146, 10147, 10148, 10149, 10150, 10151, 10152, 10153, 10154, 10155, 10156, 10157, 10158, 10160, 10161, 10162, 10164, 10165, 10166, 10167, 10168, 10169, 10170, 10171, 10172, 10174, 10176, 10177, 10178, 10179, 10180, 10181, 10183, 10184, 10185, 10186, 10187, 10188, 10190, 10191, 10192, 10193, 10194, 10195, 10196, 10197, 10198, 10200, 10201, 10202, 10203, 10204, 10205, 10206, 10207, 10208, 10209, 10210, 10211, 10212, 10213, 10214, 10215, 10216, 10217, 10218, 10219, 10220, 10221, 10222, 10223, 10224, 10225, 10226, 10227, 10228, 10229, 10230, 10231, 10234, 10235, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10245, 10246, 10247, 10248, 10250, 10251, 10252, 10253, 10254, 10255, 10256, 10257, 10258, 10259, 10260, 10261, 10262, 10263, 10264, 10265, 10266, 10267, 10268, 10269, 10270, 10271, 10272, 10273, 10274, 10275, 10276, 10277, 10278, 10279, 10280, 10281, 10282, 10283, 10284, 10285, 10286, 10287, 10288, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10327, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10341, 10342, 10343, 10344, 10345, 10346, 10347, 10348, 10349, 10350, 10351, 10352, 10353, 10354, 10355, 10357, 10358, 10359, 10360, 10361, 10362, 10363, 10364, 10365, 10366, 10367, 10368, 10369, 10370, 10371, 10372, 10373, 10374, 10375, 10376, 10378, 10379, 10380, 10381, 10383, 10384, 10385, 10386, 10388, 10389, 10390, 10391, 10392, 10393, 10394, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10402, 10403, 10404, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10415, 10416, 10417, 10418, 10419, 10420, 10421, 10422, 10424, 10425, 10426, 10427, 10428, 10429, 10430, 10431, 10432, 10434, 10435, 10436, 10437, 10438, 10439, 10440, 10441, 10442, 10443, 10444, 10445, 10446, 10447, 10448, 10449, 10450, 10451, 10452, 10453, 10454, 10455, 10456, 10457, 10458, 10459, 10460, 10461, 10462, 10463, 10464, 10465, 10466, 10467, 10468, 10469, 10470, 10471, 10472, 10473, 10474, 10475, 10476, 10477, 10478, 10479, 10480, 10481, 10482, 10483, 10484, 10485, 10486, 10487, 10488, 10489, 10490, 10491, 10492, 10494, 10495, 10496, 10497, 10498, 10499, 10500, 10502, 10503, 10504, 10505, 10506, 10507, 10508, 10510, 10511, 10512, 10513, 10514, 10515, 10516, 10517, 10518, 10519, 10520, 10521, 10522, 10523, 10525, 10526, 10527, 10528, 10530, 10531, 10532, 10533, 10534, 10535, 10536, 10537, 10538, 10539, 10540, 10541, 10542, 10543, 10545, 10546, 10547, 10548, 10549, 10550, 10551, 10552, 10553, 10554, 10555, 10556, 10557, 10558, 10559, 10560, 10561, 10562, 10563, 10564, 10565, 10566, 10567, 10568, 10569, 10570, 10571, 10572, 10573, 10574, 10575, 10576, 10577, 10578, 10579, 10580, 10581, 10582, 10583, 10584, 10585, 10586, 10587, 10588, 10589, 10590, 10591, 10592, 10593, 10594, 10595, 10596, 10597, 10598, 10599, 10600, 10601, 10602, 10603, 10604, 10605, 10606, 10607, 10608, 10609, 10610, 10611, 10612, 10613, 10614, 10615, 10616, 10617, 10618, 10619, 10621, 10622, 10623, 10624, 10625, 10626, 10627, 10628, 10629, 10630, 10631, 10632, 10633, 10634, 10635, 10636, 10637, 10638, 10639, 10640, 10641, 10642, 10643, 10644, 10645, 10646, 10647, 10648, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10662, 10663, 10664, 10665, 10666, 10667, 10668, 10669, 10670, 10671, 10672, 10673, 10674, 10675, 10676, 10677, 10678, 10679, 10680, 10681, 10682, 10683, 10684, 10685, 10686, 10687, 10688, 10689, 10690, 10691, 10692, 10693, 10694, 10695, 10696, 10697, 10698, 10699, 10700, 10701, 10702, 10703, 10704, 10705, 10706, 10707, 10708, 10710, 10712, 10713, 10714, 10715, 10717, 10718, 10720, 10721, 10722, 10723, 10724, 10725, 10726, 10727, 10728, 10730, 10731, 10733, 10734, 10735, 10736, 10737, 10738, 10739, 10740, 10741, 10742, 10743, 10744, 10745, 10747, 10748, 10749, 10750, 10751, 10752, 10753, 10755, 10756, 10757, 10758, 10759, 10760, 10761, 10762, 10763, 10764, 10765, 10766, 10767, 29002, 29003, 29005, 29007, 29014, 29016, 29018, 29022, 29024, 29025, 29026, 29027, 29034, 29035, 29037, 29038, 29044, 29045, 29049, 29054, 29056, 29057, 29062, 29070, 29086, 29092, 29097, 29107, 29111, 29113, 29124, 29138, 64015, 64040, 64051, 64117, 64135, 64151, 64152, 64153, 64158, 64163, 64167, 64168, 64173, 90029, 90030, 90031, 90033, 90036, 90037, 90041, 90042, 90045, 90046, 90047, 90050, 90057, 90058, 90060, 90062, 90063, 90066, 90070, 90072, 90073, 90077, 90078, 90079, 90080, 90081, 90082, 90084, 90086, 90087, 90089, 90091, 90092, 90094, 90096, 90097, 90098, 90099, 90100, 90102, 90105, 90106, 90107, 90117, 90118, 90120, 90123, 90124, 90129, 90131, 90132, 90136, 90137, 90139, 90140, 90141, 90143, 90147, 90150, 90151, 90152, 90153, 90154, 90156, 90157, 90159, 90160, 90161, 90162, 90163, 90167, 90168, 90169, 90175, 90177, 90180, 90182, 90185, 90187, 90205, 90208, 90213, 90218, 90221, 90223, 95003, 95008, 95009, 95011, 95012, 95013, 95014, 95015, 95016, 95017, 95018, 95019, 95020, 95021, 95022, 95023, 95024, 95025, 95029, 95030, 95031, 95032, 95033, 95034, 95035, 95036, 95037, 95038, 95039, 95040, 95041, 95042, 95043, 95044, 95045, 95047, 95048, 95049, 95050, 95051, 95052, 95053, 95054, 95055, 95056, 95057, 95059, 95060, 95061, 95062, 95063, 95064, 95065, 95066, 95067, 95068, 95069, 95071, 95072, 95073, 95074, 95075, 95076, 95077, 95078, 95079, 95080, 95081, 95082, 95083, 95084, 95085, 95086, 95087, 95088, 95089, 95090, 95091, 95092, 95093, 95094, 95095, 95096, 95097, 95098, 95099, 95100, 95101, 95102, 95103, 95104, 95105, 95106, 95107, 95108, 95109, 95110, 95111, 95112, 95113, 95114, 95116, 95117, 95118, 95119, 95120, 95121, 95122, 95123, 95124, 95125, 95126, 95127, 95128, 95129, 95130, 95131, 95132, 95133, 95134, 95135, 95136, 95137, 95138, 95139, 95140, 95141, 95142, 95143, 95144, 95145, 95146, 95147, 95149, 95150, 95151, 95152, 95153, 95154, 95155, 95156, 95157, 95158, 95159, 95161, 95162, 95163, 95164, 95165, 95167, 95168, 95169, 95170, 95171, 95172, 95173, 95175, 95176, 95177, 95178, 95179, 95180, 95182, 95183, 95184, 95185, 95186, 95187, 95188, 95189, 95190, 95191, 95192, 95193, 95194, 95195, 95196, 95197, 95198, 95199, 95200, 95201, 95202, 95203, 95204, 95205, 95206, 95207, 95208, 95210, 95212, 95213, 95214, 95215, 95216, 95217, 95218, 95219, 95220, 95221, 95222, 95223, 95224, 95225, 95226, 95227, 95228, 95229, 95231, 95232, 95233, 95234, 95235, 95236, 95237, 95238, 95239, 95240, 95241, 95242, 95243, 95244, 95245, 95246, 95247, 95249, 95250, 95251, 95252, 95253, 95254, 95255, 95256, 95257, 95258, 95259, 95260, 95261, 95262, 95263, 95264, 95265, 95266, 95267, 95268, 95269, 95270, 95271, 95272, 95273, 95274, 95275, 95276, 95277, 95278, 95279, 95280, 95281, 95282, 95283, 95284, 95285, 95286, 95287, 95288, 95289, 95290, 95291, 95292, 95293, 95294, 95296, 95297, 95298, 95299, 95300, 95301, 95302, 95303, 95304, 95305, 95308, 95309, 95310, 95311, 95312, 95313, 95314, 95315, 95316, 95317, 95318, 95319, 95320, 95321, 95322, 95323, 95324, 95325, 95326, 95327, 95328, 95329, 95330, 95331, 95332, 95333, 95334, 95335, 95336, 95337, 95338, 95339, 95340, 95342, 95343, 95344, 95345, 95346, 95347, 95348, 95349, 95350, 95351, 95352, 95353, 95354, 95355, 95356, 95357, 95358, 95359, 95360, 95361, 95362, 95363, 95364, 95365, 95366, 95369, 95370, 95371, 95374, 95375, 95376, 95377, 95378, 95379, 95380, 95381, 95382, 95383, 95385, 95386, 95387, 95388, 95389, 95390, 95391, 95393, 95394, 95395, 95396, 95397, 95398, 95399, 95400, 95401, 95402, 95403, 95404, 95405, 95406, 95407, 95408, 95409, 95410, 95411, 95412, 95413, 95414, 95415, 95416, 95417, 95418, 95419, 95420, 95421, 95422, 95424, 95425, 95426, 95427, 95428, 95429, 95430, 95431, 95432, 95433, 95434, 95435, 95436, 95437, 95438, 95439, 95440, 95441, 95442, 95443, 95444, 95445, 95446, 95447, 95448, 95449, 95450, 95451, 95452, 95453, 95454, 95455, 95456, 95457, 95458, 95459, 95461, 95462, 95463, 95464, 95465, 95466, 95467, 95468, 95469, 95470, 95471, 95472, 95473, 95474, 95475, 95476, 95477, 95479, 95480, 95481, 95482, 95483, 95484, 95485, 95486, 95487, 95488, 95489, 95490, 95491, 95492, 95493, 95494, 95495, 95496, 95497, 95498, 95499, 95500, 95501, 95502, 95503, 95504, 95505, 95506, 95507, 95508, 95509, 95510, 95511, 95512, 95513, 95514, 95515, 95516, 95517, 95518, 95519, 95520, 95521, 95522, 95523, 95524, 95525, 95526, 95527, 95528, 95529, 95530, 95531, 95532, 95533, 95534, 95535, 95536, 95537, 95538, 95540, 95541, 95542, 95543, 95544, 95545, 95546, 95547, 95548, 95549, 95550, 95551, 95552, 95554, 95555, 95556, 95557, 95558, 95559, 95560, 95561, 95563, 95564, 95565, 95566, 95567, 95568, 95569, 95570, 95571, 95572, 95573, 95574, 95575, 95577, 95578, 95579, 95580, 95581, 95582, 95583, 95584, 95585, 95586, 95587, 95588, 95589, 95590, 95591, 95592, 95595, 95596, 95597, 95598, 95599, 95600, 95601, 95602, 95603, 95604, 95605, 95606, 95607, 95608, 95609, 95610, 95611, 95612, 95613, 95614, 95615, 95616, 95617, 95618, 95620, 95621, 95622, 95623, 95624, 95625, 95626, 95627, 95628, 95629, 95630, 95631, 95632, 95633, 95634, 95635, 95636, 95637, 95638, 95639, 95640, 95641, 95642, 95643, 95644, 95645, 95646, 95647, 95648, 95649, 95650, 95651, 95652, 95653, 95654, 95655, 95656, 95657, 95658, 95659, 95660, 95661, 95662, 95664, 95665, 95666, 95667, 95668, 95669, 95670, 95671, 95672, 95673, 95674, 95675, 95676, 95677, 95678, 95679, 95680, 95681, 95682, 95683, 95684, 95685, 95686, 95687, 95688, 95689, 95690, 95691, 95692, 95693, 95694, 95695, 95696, 95697, 95698, 95699, 95700, 95702, 95703, 95704, 95705, 95706, 95707, 95708, 95709, 95710, 95711, 95712, 95713, 95714, 95715, 95716, 95718, 95719, 95720, 95721, 95722, 95723, 95724, 95725, 95726, 95727, 95729, 95730, 95731, 95732, 95733, 95734, 95735, 95736, 95737, 95738, 95739, 95740, 95741, 95742, 95743, 95744, 95745, 95746, 95747, 95748, 95749, 95750, 95751, 95752, 95753, 95754, 95755, 95756, 95757, 95758, 95759, 95760, 95761, 95764, 95765, 95767, 95768, 95769, 95770, 95772, 95773, 95774, 95775, 95776, 95777, 95778, 95779, 95780, 95781, 95782, 95783, 95784, 95785, 95786, 95787, 95788, 95789, 95790, 95791, 95792, 95793, 95794, 95795, 95796, 95797, 95798, 95799, 95800, 95801, 95802, 95803, 95804, 95805, 95806, 95807, 95808, 95809, 95810, 95811, 95812, 95814, 95815, 95816, 95817, 95818, 95819, 95820, 95821, 95822, 95823 System Code #728321, Serial #: 310001, 310002, 310003, 310004, 310005, 310006, 310007, 310010, 310011, 310012, 310013, 310014, 310015, 310016, 310017, 310018, 310019, 310020, 310021, 310022, 310023, 310024, 310025, 310026, 310027, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310036, 310037, 310038, 310040, 310041, 310043, 310044, 310045, 310046, 310047, 310048, 310049, 310050, 310051, 310052, 310053, 310054, 310055, 310056, 310057, 310058, 310059, 310060, 310061, 310062, 310063, 310065, 310066, 310067, 310068, 310069, 310071, 310072, 310073, 310074, 310075, 310076, 310077, 310078, 310079, 310080, 310082, 310083, 310084, 310085, 310086, 310087, 310088, 310089, 310090, 310091, 310092, 310093, 310094, 310095, 310096, 333001, 333007 System Code #728323, Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047.320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: 800-722-9377
• Manufacturer Reason for Recall: Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images.
• FDA Determined Cause: Software design
• Action: Philips Healthcare sent an Urgent Medical device Correction letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to resolve the issue and a Philips Field Service Engineer will contact each site to schedule the software installation. For questions contact your local Philips representative or local Philips Healthcare office.
• Quantity in Commerce: 2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units.
• Distribution: USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.