Class 2 Device Recall Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP

• Date Initiated by Firm: December 20, 2012
• Date Posted: March 13, 2013
• Recall Status: Terminated on April 17, 2014
• Recall Number: Z-0945-2013
• Recall Event ID: 64401
• 510(K)Number: K010817 K012009 K033326 K033357 K060937
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems.; ; These devices are 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
• Code Information: System Code #728256, Serial #: 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System Code #728251, Serial #: 3008,3098,4006,4007,4010,4011,4012,4016,4023,4031,4039,4050,4058,4061,4062,4063,4064,4065,4066,4067,40004,40005,40006,40007,40008,40009,40010,40011,40012,40014,40015,40016,40017,40018,40021,40025,40028,40030,40032 System Code #728246, Serial #: 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6509,30019,30041,30044,30067,30069,30070,30071,30097,30119,40002,40022,40027,40035,50002,50003,50004,50009,50010,50011,50013,50014,50015,50018,50022,50023,50029,50031,50032,50033,50035,50036,50041,50042,50044,50045,50046,50049,50050,50051,50052,50055,50058,50059,50061,50062,50063,50064,50065,50066,50068,50069,50070,50073,50074,50078,50080,50081,50082,50083,50084,50086,50087,50089,50090,50091,50092,50093,50094,50095,50097,50098,50099,50101,50102,50103,50106,50109,50110,50114,50122,50124,50125,50126,50128,50129,50131,50132,50133,50134,50135,50136,50137,50138,50140,50141,50142,50153,50154,50155,50156,50157,50158,50159,50160,50161,50162,50163,50164,50165,50166,50167,50168,50169,50170,50171,50172,50173,50175,50176,50177,50178,50179,50180,50181,50182,50183,60015,60020 System Code #728240, Serial #: 5003,5043,5175,5251,5284,5373,5374,5390,5395,5413,5430,5431,5436,5440,5445,5454,5455,5456,5465,5467,5469,5470,5472,5475,5476,5483,5495,5499,5500,5512,5521,5527,5822,6006,6009,6010,6011,6013,6021,6024,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036,6041,6045,6046,6047,6048,6049,6054,6055,6057,6058,6059,6060,6064,6066,6067,6069,6070,6071,6072,6075,6080,6081,6082,6083,6085,6089,6090,6095,6096,6099,6100,6101,6102,6103,6104,6105,6106,6112,6113,6115,6117,6119,6121,6123,6127,6129,6130,6131,6133,6134,6136,6137,6138,6139,6141,6144,6146,6148,6150,6154,6155,6156,6157,6159,6160,60002,60005,60009,60011,60012,60014,60018,60021,60022,60025,60027,60029 System Code #728235, Serial #: 9031,9036,9039,9061,9085,9088,9094,9097,9103,9104,9114,9116,9125,9129,9130,9132,9144,9146,9147,9149,9152,9153,9156,9157,9164,9167,9168,9169,9170,9174,9178,9181,9183,9186,9188,9189,9190,9191,9200,9203,9211,9212,9220,9233,9260,9265,9272,29008,29010,29011,29012,29015,29017,29019,29020,29023,29024,29028,29030,29033,29042,29043,29046,29048,29051,29055,29059,29060,29061,29062,29065,29067,29070,29071,29072,29075,29077,29078,29080,29084,29085,29086,29087,29088,29089,29090,29091,29092,29093,29094,29095,29096,29097,29098,29099,29100,29101,29102,29103,29104,29105,29106,29107,29108,29109,29111,29112,29113,29114,29116,29117,29118,29119,29120,29121,29122,29123,29124,29125,29126,29127,29128,29129,29130,29131,29132,29134,29135,29136,29137,29138,29139,29140,29141,29142,29143,29144,29145,29146,29147,29148,29149,29150,29151,29152,29153,90034,90043,90046,90048,90051,90053,90056,90058,90059,90064,90065,90069,90071,90075,90076,90083,90095,90101,90103,90108,90110,90111,90121,90122,90125,90126,90128,90130,90134,90144,90145,90146,90148,90149,90153,90155,90164,90166,90171,90172,90173,90176,90178,90179,90181,90184,90186,90187,90189,90191,90192,90195,90196,90197,90200,90204,90206,90213,90214,90221,90223,90224,90225,90226,90227,90228,90229,90230,90231,90232,90233,90234,90235,90236,90237 System Code #728231, Serial #: 4001,4003,4016,4021,9009,9037,9038,9041,9044,9045,9048,9049,9052,9056,9059,9062,9066,9069,9074,9075,9077,9080,9087,9089,9092,9105,9108,9118,9120,9137,9142,9143,9160,9162,9166,9175,9195,9197,9201,9202,9205,9206,9208,9214,9216,9217,9501,9502,9503,9514,9522,9526,9533,9538,9540,9541,9543,9544,9547,9552,9553,9554,9556,9561,9564,9566,9568,9569,9570,9575,9577,9578,9580,9584,9585,9586,9588,9590,9592,9596,9599,9607,9612,9615,9617,9620,9625,9627,9628,9630,9640,9641,9650,9654,9659,9663,9664,9670,9672,9675,9676,9678,9684,9688,9690,9694,9695,9696,9697,9703,9706,9709,9712,9713,9714,9718,9729,9731,9735,9736,9737,9738,9740,9747,9750,9751,9758,9761,9765,9766,9767,9772,9774,9777,9780,9782,9787,9788,9792,9794,9795,9797,9805,9807,9808,9811,9812,9813,9818,9820,9822,9824,9828,9830,9833,9834,9835,9837,9838,9840,9841,9843,9846,9848,9857,9866,9870,9871,9873,9874,9877,9882,9883,9902,9909,9916,9924,9933,9939,9956,9957,9958,9959,9960,9961,9962,9963,9964,9965,9966,9967,9968,9969,9970,9971,9972,9973,9974,9975,9976,9977,9978,9979,9980,9981,9982,9983,9984,9985,9986,9987,9988,9989,9990,9991,9992,9993,9994,9995,9996,9997,9998,9999,10000,10001,10002,10003,10004,10005,10006,10007,10008,10009,10010,10011,10012,10013,10014,10015,10016,10017,10018,10019,10020,10021,10022,10023,10024,10025,10026,10027,10028,10029,10030,10031,10032,10033,10034,10035,10036,10037,10038,10039,10040,10041,10042,10043,10044,10045,10046,10047,10048,10049,10050,10051,10052,10053,10054,10056,10057,10058,10059,10060,10061,10062,10063,10064,10065,10066,10067,10068,10069,10070,10071,10072,10073,10074,10075,10076,10077,10078,10079,10080,10081,10082,10083,10084,10085,10086,10087,10088,10089,10090,10091,10092,10093,10094,10095,10096,10097,10098,10099,10100,10101,10102,10103,10104,10105,10106,10107,10108,10109,10110,10111,10112,10113,10114,10115,10116,10117,10118,10119,10120,10121,10122,10123,10124,10125,10126,10127,10128,10129,10130,10131,10132,10133,10134,10135,10136,10137,10138,10139,10140,10141,10142,10143,10144,10145,10146,10147,10148,10149,10150,10151,10152,10153,10154,10155,10156,10157,10158,10159,10160,10161,10162,10163,10164,10165,10166,10167,10168,10169,10170,10171,10172,10173,10174,10175,10176,10177,10178,10179,10180,10181,10182,10183,10184,10185,10186,10187,10188,10189,10190,10191,10192,10193,10194,10195,10196,10197,10198,10199,10200,10201,10202,10203,10204,10205,10206,10207,10208,10209,10210,10211,10212,10213,10214,10215,10216,10217,10218,10219,10220,10221,10222,10223,10224,10225,10226,10227,10228,10229,10230,10231,10232,10233,10234,10235,10236,10237,10238,10239,10241,10242,10243,10244,10245,10247,10248,10249,10250,10251,10252,10253,10254,10255,10256,10257,10258,10259,10260,10261,10262,10263,10264,10265,10266,10267,10268,10269,10270,10271,10272,10273,10274,10275,10276,10277,10278,10279,10280,10281,10282,10283,10284,10285,10286,10287,10288,10289,10290,10291,10292,10293,10294,10295,10296,10297,10298,10299,10300,10301,10302,10303,10304,10305,10306,10307,10308,10309,10310,10311,10312,10313,10314,10315,10316,10317,10318,10319,10320,10321,10322,10323,10324,10325,10326,10327,10328,10330,10331,10332,10333,10334,10335,10336,10337,10338,10339,10340,10341,10342,10343,10344,10345,10346,10347,10348,10349,10350,10351,10352,10353,10354,10355,10356,10357,10358,10359,10360,10361,10362,10363,10364,10365,10366,10367,10368,10369,10370,10371,10372,10373,10374,10375,10376,10377,10378,10379,10380,10381,10382,10383,10384,10385,10386,10387,10388,10389,10390,10391,10392,10393,10394,10395,10396,10397,10398,10399,10400,10401,10402,10403,10404,10405,10406,10407,10408,10409,10410,10411,10412,10413,10414,10415,10416,10417,10418,10419,10420,10421,10422,10423,10424,10425,10426,10427,10428,10429,10430,10431,10432,10433,10434,10435,10436,10437,10438,10439,10440,10441,10442,10443,10444,10445,10446,10447,10448,10449,10450,10451,10452,10453,10454,10455,10456,10458,10459,10460,10461,10462,10463,10464,10465,10466,10467,10468,10469,10470,10471,10472,10473,10474,10475,10476,10477,10478,10479,10480,10481,10482,10483,10484,10485,10486,10487,10488,10489,10490,10491,10492,10493,10494,10495,10496,10497,10498,10499,10500,10501,10502,10503,10504,10505,10506,10507,10508,10510,10511,10513,10514,10515,10516,10517,10518,10519,10520,10521,10522,10523,10524,10525,10526,10527,10528,10529,10530,10531,10532,10533,10534,10535,10536,10537,10538,10539,10540,10541,10542,10543,10544,10545,10546,10547,10548,10549,10550,10551,10552,10553,10554,10555,10556,10557,10558,10559,10560,10561,10562,10563,10564,10565,10566,10567,10568,10569,10570,10571,10572,10573,10574,10575,10576,10577,10578,10579,10581,10582,10583,10584,10585,10586,10587,10588,10589,10590,10591,10592,10593,10594,10595,10596,10597,10598,10599,10600,10601,10602,10603,10604,10605,10606,10607,10608,10609,10610,10611,10612,10613,10614,10615,10616,10617,10618,10619,10620,10621,10622,10623,10624,10625,10626,10627,10628,10629,10630,10631,10632,10633,10634,10635,10636,10637,10638,10639,29016,29027,29035,29037,29044,29045,29049,29057,29066,64015,64045,64051,90029,90036,90037,90041,90045,90070,90072,90077,90080,90081,90082,90085,90086,90089,90091,90097,90099,90106,90107,90117,90120,90123,90124,90132,90135,90136,90137,90141,90151,90152,90154,90156,90161,90162,90167,90168,90169,90170,90177,90182,90185,95009,95011,95013,95016,95020,95021,95022,95023,95025,95026,95030,95033,95034,95035,95036,95038,95043,95044,95045,95050,95052,95054,95055,95056,95058,95060,95062,95065,95067,95068,95069,95071,95073,95074,95075,95078,95079,95081,95084,95087,95088,95090,95092,95093,95095,95096,95097,95098,95100,95103,95104,95105,95106,95107,95108,95114,95116,95118,95120,95123,95125,95126,95130,95132,95133,95134,95136,95137,95138,95139,95140,95144,95145,95146,95150,95151,95153,95156,95158,95159,95160,95163,95164,95165,95166,95176,95178,95191,95193,95198,95199,95203,95206,95207,95208,95212,95216,95219,95221,95223,95224,95225,95226,95232,95237,95238,95239,95240,95241,95242,95244,95246,95249,95251,95252,95254,95256,95259,95261,95262,95263,95265,95266,95268,95270,95271,95273,95274,95275,95276,95277,95278,95281,95285,95287,95288,95291,95293,95295,95299,95300,95302,95303,95310,95311,95312,95313,95314,95315,95316,95317,95318,95319,95320,95321,95322,95323,95324,95325,95326,95327,95328,95329,95330,95331,95332,95333,95334,95335,95336,95337,95338,95339,95340,95341,95342,95343,95344,95346,95347,95348,95349,95350,95351,95352,95353,95354,95355,95356,95357,95358,95359,95360,95361,95362,95363,95364,95365,95366,95367,95368,95369,95370,95371,95372,95373,95374,95375,95376,95377,95378,95379,95380,95381,95382,95383,95384,95385,95386,95387,95388,95389,95390,95391,95392,95393,95394,95395,95396,95397,95398,95399,95400,95401,95402,95403,95404,95405,95406,95407,95408,95409,95410,95411,95412,95413,95414,95415,95416,95417,95418,95419,95420,95421,95422,95423,95424,95425,95426,95427,95428,95429,95430,95431,95432,95433,95434,95435,95436,95437,95438,95439,95440,95441,95442,95443,95444,95445,95446,95447,95448,95449,95450,95451,95452,95453,95454,95455,95456,95457,95458,95459,95460,95461,95462,95463,95464,95465,95466,95467,95468,95469,95470,95471,95472,95473,95474,95475,95476,95477,95478,95479,95480,95481,95482,95483,95484,95485,95486,95487,95488,95489,95490,95491,95492,95493,95494,95495,95496,95497,95498,95499,95500,95501,95502,95503,95504,95505,95506,95507,95508,95509,95510,95511,95512,95513,95514,95515,95516,95517,95518,95519,95520,95521,95522,95523,95524,95525,95526,95527,95528,95529,95530,95531,95532,95533,95534,95535,95536,95537,95538,95539,95540,95541,95542,95543,95544,95545,95546,95547,95548,95549,95550,95551,95552,95553,95554,95556,95557,95559,95560,95561,95562,95563,95564,95565,95566,95567,95569,95571,95572,95573,95574,95576,95577,95578,95579,95580,95581,95582,95583,95584,95585,95586,95587,95588,95589,95590,95591,95592,95593,95594,95595,95596,95597,95598,95599,95600,95601,95603,95604,95605,95606,95607,95608,95609,95610,95611,95612,95613,95614,95615,95616,95617,95618,95619,95620,95621,95622,95623,95625,95626,95627,95628,95629,95631,95632,95633,95634,95635,95636,95637,95638,95639,95640,95641,95642,95643,95644,95645,95646,95647,95648,95649,95650,95651,95652,95653,95654,95655,95656,95657,95659,95660,95661,95662,95663,95666,95667,95668,95669,95670,95671,95672,95673,95674,95675,95676,95678,95679,95680,95681,95682,95683,95684,95685,95686,95687,95688,95689,95690,95691,95692,95693,95694,95695,95696,95697,95698,95699,95700,95701,95702,95703,95704,95705,95706,95707,95708,95709,95710,95711,95712,95713,95714,95715,95716,95717,95718,95719,95721,95722,95723,95724,95725,95726,95727,95728,95729,95730,95731,95732,95733,96494 System Code # 728243, Serial #: 7006,7008,7014,7016,7019,7025,7026,7027,7029,7030,7031,7033,7039,7042,7043,7047,7049,7050,7054,7071,7073,7076,7078,7081,7084,7086,7087,7088,7093,7095,7098,7099,7101,7102,7103,7110,7113,7114,7115,7117,7122,7124,7125,7127,7128,7130,7132,7133,7134,7136,7138,7140,7141,7142,7144,7147,7150,7151,7152,7153,7154,7156,7157,7158,7159,7160,7161,7162,7163,7164,7165,7166,7167,7168,7169,7170,7171,7173,7174,7175,7177,7178,7179,7181,7183,7184,7185,7186,7187,7188,7189,7191,7192,7193,7194,7195,7196,7197,7198,7199,7201,7202,7203,7204,7205,7206,7207,7208,7209,7210,7211,7212,7213,7214,7215,7216,7217,7218,7219,7220,7221,7222,7223,7224,7225,7226,7227,7228,7229,7230,7231,7232,7233,7234,7235,7236,7237,7238,7239,7240,7241,7242,7243,7245,7246,7247,7248,7249,7250,7251,7253,7254,7255,7256,7257,7258,7259,7260,7261,7262,7263,7264,7265,7266,7267,7269,7270,7272,7273,7274,7275,7276,7277,7278,7279,7280,7281,7282,7283,7284,7285,7286,7287,7288,7289,7290,7291,7292,7293,7294,7295,7296,7297,7299,7300,7302,7303,7304,7305,7306,7307,7308,7309,7310,7311,7312,7313,7314,7315,7316,7319,7320,7321,7322,7323,7324,7325,7326,7327,7328,7329,7330,7331,7332,7333,7334,7335,7336,7337,7338,7339,7340,7341,7342,7343,7344,7345,7346,7347,7348,7349,7350,7351,7352,7353,7354,7355,7356,7357,7358,7359,7360,7361,7362,7363,7364,7365,7366,7367,7368,7369,7370,7371,7372,7373,7374,7376,7377,7378,7379,7381,7382,7385,7387,7388,7389,7391,7392,7393,7394,7395,7397,7398,7399,7400,7401,7403,7404,7405,7406,7409,7410,7411,7412,7413,7414,7415,7416,7417,7418,7419,7420,7421,7422,7423,7424,7425,7426,7428,7429,7431,7432,7433,7434,7435,7436,7437,7438,7440,7441,7442,7443,7444,7445,7446,7447,7448,7449,7450,7451,7454,7455,7456,7457,7459,7460,7461,7462,7463,7464,7465,7466,7467,7468,7469,7470,7471,7472,7473,7474,7475,7476,7477,7478,7479,7480,7481,7482,7483,7484,7485,7487,7488,7489,7490,7491,7492,7493,7494,7495,7496,7497,7498,7499,7500,7501,7502,7503,7504,7505,7506,7507,7508,7509,7511,7512,7513,7515,7516,7517,7518,7519,7521,7522,7523,7524,7525,7526,7527,7528,7529,7530,7531,7532,7533,7534,7535,7536,7537,7538,7539,7540,7541,7542, 7544,7545,7546,7547,7548,7549,7550,7551,7552,7553,7554,7555,7556,7557,7558,7559,7560,7561,7562,7563,7564,7565,7566,7567,7568,7569,7570,7572,7573,7574,7575,7576,7577,7578,7579,7580,7581,7582,7583,7584,7585,7586,7587,7588,7589,7590,7591,7592,7593,7595,7596,7597,7598,7599,7601,7602,7603,7604,7605,7606,7607,7608,7609,7610,7611,7612,7613,7614,7615,7616,7617,7618,7620,7622,7623,7624,7625,7626,7627,7628,7629,7630,7631,7632,7633,7634,7635,7637,7638,7639,7640,7641,7642,7643,7644,7645,7646,7647,7648,7649,7650,7652,7655,7656,7657,7658,7659,7661,7662,7663,7665,7666,7667,7671,7672,7673,7674,7675,7677,7678,7679,7680,7681,7682,7684,7685,7686,7687,7689,7690,7691,7692,7693,7695,7696,7698,7699,7700,7701,7702,7703,7704,7705,7706,7707,7709 System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710 System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710 System Code # 728306, Serial #: 100019,100020,100021,100022,100023,100024,100025,100028,100031,100032,100037,100038,100039,100040,100042,100043,100044,100045,100046,100047,100048,100049,100050,100051,100052,100053,100054,100055,100056,100057,100058,100059,100060,100061,100062,100063,100064,100065,100066,100067,100068,100069,100070,100071,100072,100073,100074,100077,100078,100079,100081,100082,100083,100084,100085,100086,100087,100088,100089,100090,100091,100092,100093,100094,100095,100096,100097,100098,100099,100100,100101,100102,100103,100104,100105,100106,100107,100108,100109,100110,100111,100112,100113,100114,100115,100116,100117,100118,100119,100120,100121,100122,100123,100124,100125,100126,100127,100128,100129,100130,100131,100132,100133,100134,100135,100136,100137,100138,100139,100140,100141,100142,100143,100144,100145,100146,100147,100148,100149,100150,100151,100152,100153,100154,100155,100157,100158,100159,100160,100161,100162,100163,100164,100165,100166,100167,100168,100169,100170,100171,100172,100173,100174,100175,100176,100177,100178,100179,100180,100181,100182,100183,100184,100185,100186,100187,100188,100189,100190,100191,100192,100193,100194,100195,100196,100197,100198,100199,100200,100201,100202,100203,100204,100205,100206,100207,100208,100209,100210,100211,100212,100213,100214,100215,100216,100217,100218,100219,100220,100221,100222,100223,100224,100225,100226,100227,100228,100229,100230,100231,100232,100233,100234,100235,100236,100238,100240,100241,100242,100243,100244,100245,100246,100247,100248,100249,100250,100251,100252,100253,100254,100255,100256,100257,100258,100259,100260,100261,100262,100263,100264,100265,100266,100267,100268,100269,100270,100271,100272,100273,100274,100275,100276,100277,100278,100279,100280,100281,100282,100283,100284,100285,100286,100287,100288,100289,100290,100291,100292,100293,100294,100295,100296,100297,100298,100299,100300,100301,100302,100303,100304,100305,100306,100307,100308,100309 System Code #728311, Serial #: 200003,200004,200005,200006,200007,200008,200009,200010,200012,200013,200014,200015,200016,200017,200018,200019,200020,200021,200022,200023,200024,200025,200026,200027,200028,200029,200030,200031,200032,200033,200034,200035,200036,200037,200038,200039,200040,200041,200042,200043,200044,200045,200046,200047,200048,200049,200050,200051,200052,200053,200054,200055,200056,200057,200058,200059,200060,200061,200062,200063,200064,200065,200066,200067,200068,200069,200070,200071,200073,200074,200075,200076,200077,200078,200079,200080,200081,200082,200083,200084,200085,200086,200087,200088,200089,200090,200091,200092,200093 System Code #728231, Serial #: 310001, 310002, 310003 System Code #728130, Serial #: 8020,8022,8039,8060,8065,8067,8079,8089,8100,8105,8121,8144,8153,8169,8189,8205,8209,8211,8214,8249,8251,8252,8253,8397,8399,20302,80001,80007,80011,80015,80020
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Michael McAndrew; 800-722-9377 Ext. 5
• Manufacturer Reason for Recall: Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.
• FDA Determined Cause: Component design/selection
• Action: Philips Healthcare sent a "Urgent Medical Device Correction" letter dated December 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed Philips received reports from the field stating that the screws holding the vertical brake together failed. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information please contact your local Philips representative or local Philips Healthcare office. For North America and Canada Contact the Customer Care Solutions Center at ( 1-800-722-9377, option 5: Enter Site ID or follow the prompts.
• Quantity in Commerce: 4797 Units
• Distribution: Worldwide Distribution - 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and 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 = MARCONI MEDICAL SYSTEMS, INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.