Class 2 Device Recall Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography

• Date Initiated by Firm: September 28, 2012
• Date Posted: March 05, 2013
• Recall Status: Terminated on December 26, 2013
• Recall Number: Z-0906-2013
• Recall Event ID: 64259
• 510(K)Number: K961464
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. ; ; The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is 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: Model 728260, Serial #, 3467,5610,6151,6204,6209,6221,6437,6483,6543,6636,6658,6717,6788,6865,7154,7186,7253,7470, 7507,7576,7579,7639,7690,7692,7708,7835,7977,8099,8255,8332,8443,8756,8757,8890,8922,9079, 9201,9395,9422,10085,10086,10090,10102,10138,10155,10180,10197,10216,10240,10261,10264,10271, 10312, 10324,10328,10346,10355,10359,10378,10383,10389,10422,10427,10431,10435,10437,10442, 10455,10456,10470,10476,10492,10537,10547,10561,10584,10598,10604,10606,10622,10630,10646, 10672,10686,10699,10722,10727,10738,10745,10747,10770,10776,10778,10796,10798,10817,10821, 10822,10823,10838,10841,10874,10889,10890,10897,10952,10953,10965,10980,10985,10988,10998, 11007,11010,11025,11036,11037,11043,11051,11054,11058,11062,11065,11080,11083,11085,11086, 11088,11089,11105,11107,11113,11121,11127,11128,11140,11141,11147,11148,11149,11151,11152, 11153,11166,11169,11173,11174,11208,11221,11230,11232,11241,11243,11260,11262,11267,11274, 11278,11280,11282,11291,11314,11317,11324,11334,11339,11341,11557,11561,11564,11567,11572, 11577,11581,11585,11603,11610,11612,11620,11622,11630,11631,11633,11644,11649,11650,11656, 11657,11659,11660,11662,11663,11667,11668,11670,11673,11674,11684,11685,11692,11694,11696, 11699,11700,11703,11706,11708,11711,11714,11717,11718,11720,11729,11739,11740,11742,11743, 11744,11745,11747,11748,11749,11750,11751,11753,11754,11755,11756,11758,11760,11762,11765, 11766,11768,11769,11770,11772,11773,11774,11776,11779,11780,11781,11782,11784,11785,11788, 11790,11791,11793,11794,11795,11796,11797,11798,11800,11801,11802,11803,11804,11805,11806, 11807,11808,11809,11810,11812,11813,11814,11816,11817,11818,11819,11822,11823,11830,11831, 11832,11833,11834,11838,11839,11840,11841,11842,11843,11844,11845,11846,11847,11848,11850, 11851,11852,11854,11856,11858,11859,11862,11863,11864,11865,11866,11868,11869,11870,11873, 11874,11877,11878,11879,11880,11881,11882,11883,11884,11885,11886,11888,11889,11890,11891, 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12838,12839,12840,12844,12845,12846,12847,12848,12849,12850,12851,12861,12865,12874,12875, 12877,12878,12879,12900,12901,12902,12904,12905,12907,12908,12909,12911,12913,12917,12919, 12920,12922,12923,12925,12926,12927,12928,12929,12930,12931,12932,12935,12937,12938,12939, 12940,12941,12942,12944,12947,12949,12953,12956,12957,12958,12960,12961,12962,12963,12964, 12965,12966,12967,12968,12969,12970,12971,12972,12973,12974,12976,12978,12979,12980,12983, 12985,12986,12987,12988,12992,12994,12996,12997,12999,13000,13002,13003,13004,13005,13007, 13008,13009,13010,13013,13014,13015,13016,13017,13018,13019,13020,13022,13023,13024,13025, 13026,13027,13028,13029,13031,13034,13035,13036,13039,13041,13042,13043,13044,13046,13047, 13060,13061,13062,13063,13064,13065,13066,13067,13068,13069,13070,13071,13072,13073,13074, 13075,13076,13077,13078,13079,13080,13081,13082,13083,13084,13086,13088,13089,13101,13102, 13103,13104,13105,13109,13110,13113,13114,13115,13116,13117,13118,13119,13120,13121,13122, 13123,13125,13128,13129,13131,13132,13133,13134,13135,13136,13137,13138,13139,13142,13148, 13149,13150,13151,13152,13153,13154,13155,13156,13157,13158,13159,13160,13163,13164,13165, 13166,13167,13168,13169,13170,13171,13173,13177,13178,13179,13180,13181,13182,13183,13184, 13185,13186,13188,13189,13190,13191,13192,13194,13195,13196,13197,13198,13199,13201,13202, 13203,13204,13206,13207,13208,13213,13214,13215,13217,13218,13219,13220,13221,13223,13224, 13225,13226,13227,13228,13229,13230,13231,13232,13233,13234,13238,13239,13240,13241,13242, 13244,13245,13246,13249,13263,13264,13265,13266,13272,13273,13274,13277,13278,13279,13298, 13299,13301,13302,13303,13304,13305,13306,13307,13308,13309,13310,13312,13313,13314,13315, 13316,13317,13318,13320,13321,13322,13323,13324,13325,13326,13327,13328,13329,13330,13331, 13332,13333,13334,13336,13337,13341,13342,13343,13344,13348,13351,13353,13355,13359,13362, 13363,13365,13366,13367,13368,13370,13371,13373,13374,13375,13376,13377,13378,13379,13381, 13382,13385,13386,13389,13391,13393,13397,13399,13400,13401,13402,13403,13404,13406,13407, 13408,13410,13411,13412,13415,13416,13417,13420,13421,13423,13425,13427,13428,13429,13430, 13431,13438,13439,13440,13443,13444,13445,13447,13448,13450,13451,13453,13454,13455,13456, 13458,13459,13463,13465,13466,13467,13471,13472,13473,13474,13475,13476,13477,13478,13500, 13501,13502,13508,13509,13510,13511,13512,13513,13514,13515,13516,13517,13518,13519,13520, 13521,13522,13523,13524,13525,13526,13527,13528,13529,13530,13531,13532,13533,13534,13535, 13536,13537,13538,13539,13540,13541,13542,13543,13544,13545,13546,13547,13548,13549,13550, 13552,13553,13556,13557,13558,13560,13561,13562,13563,13564,13566,13567,13568,13569,13570, 13571,13572,13574,13575,13578,13579,13580,13581,13582,13584,13585,13586,13587,13588,13589, 13590,13591,13592,13593,13594,13595,13596,13598,13599,13600,13602,13603,13604,13605,13606, 13607,13608,13609,13610,13611,13612,13613,13614,13616,13617,13619,13622,13624,13625,13626, 13627,13628,13629,13634,13637,13638,13639,13640,13641,13642,13643,13644,13645,13648,13649, 13651,13652,13653,13654,13655,13656,13657,13658,13659,13661,13664,13666,13667,13672,13675, 13679,13680,13681,13684,13686,13690,13693,13694,13696,13697,13698,13715,13716,13718,13727, 13739,13750,13751,13752,13753,13754,13755,13756,13757,13758,13759,13760,13761,13762,13763, 13764,13765,13766,13767,13768,13769,13770,13771,13772,13773,13774,13775,13776,13777,13779, 13784,13785,13786,13787,13788,13789,13790,13791,13792,13793,13794,13796,13797,13798,13799, 13803,13804,13805,13806,13808,13809,13810,13811,13814,13816,13817,13823,13824,13825,13846, 13847,13848,13849,13850,13851,13852,13853,13856,13857,13859,13862,13863,13864,13867,13868, 13869,13870,13871,13872,13875,13876,13877,13878,13880,13883,13884,13886,13887,13892,13893, 13894,13895,13896,13897,13899,13900,13901,13902,13903,13904,13905,13906,13907,13908,13909, 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13971,13972,13974,13976,13977,13978,13980,13982,13983,13984,13986,13987,13988,13989,13990,13992,13993,13995,13997,13998,13998,13999,14000,14005,14006,14007,14008,14009,14010,14011,14012,14013,14014,14015,14016,14017,14018,14019,14020,14021,14022,14023,14024,14025,14026,14027,14028,14029,14030,14031,14032,14033,14034,14035,14036,14037,14038,14039,14040,14050,14054,14055,14058,14059,14061,14062,14063,14064,14065,14068,14069,14070,14071,14072,14073,14074,14075,14076,14077,14078,14079,14080,14081,14082,14083,14084,14085,14086,14087,14088,14089,14090,14091,14095,14096,14097,14098,14100,14101,14102,14103,14105,14106,14107,14108,14109,14110,14111,14113,14114,14115,14117,14118,14119,14120,14121,14122,14123,14125,14126,14129,14130,14131,14132,14133,14135,14136,14137,14138,14139,14140,14141,14142,14147,14148,14149,14152,14157,14158,14159,14162,14163,14164,14165,14167,14170,14174,14219,14221,14223,14224,14248,14250,14254,14255,14256,14257,14258,14259,14260,14261,14262,14263,14264,14265,14266,14267,14268,14269,14269,14270,14271,14274,14275,14276,14277,14278,14279,14282,14284,14285,14286,14287,14288,14289,14290,14291,14293,14295,14296,14297,14298,14299,14300,14301,14302,14303,14304,14305,14306,14307,14309,14311,14313,14314,14315,14316,14317,14318,14319,14320,14321,14322,14323,14324,14325,14327,14328,14329,14330,14331,14332,14333,14334,14335,14336,14337,14338,14339,14340,14341,14342,14343,14344,14345,14346,14347,14348,14349,14350,14351,14352,14353,14354,14355,14356,14357,14358,14359,14360,14361,14362,14363,14365,14366,14367,14368,14369,14370,14373,14374,14375,14376,14377,14378,14379,14380,14381,14382,14383,14384,14385,14386,14388,14389,14390,14391,14393,14394,14395,14396,14398,14399,14400,14402,14403,14450,14451,14452,14453,14454,14455,14456,14457,14458,14459,14460,14461,14462,14463,14464,14465,14466,14467,14468,14469,14470,14471,14472,14473,14474,14475,14476,14477,14478,14479,14481,14482,14483,14486,14489,14490,14491,14492,14493,14494,14495,14496,14497,14498,14499,14500,14504,14534,14535,14536,14537,14538,14539,14540,14541,14558,14559,14560,14561,14562,14563,14564,14566,14567,14568,14569,14570,14571,14572,14586,14587,14588,14595,14596,14597,14598,14599,14600,14603,14604,14605,14606,14607,14609,14610,14611,14613,14614,14617,14619,14620,14621,14622,14625,14627,14628,14629,14630,14631,14632,14633,14634,14635,14637,14638,14639,14640,14642,14644,14645,14647,14648,14649,14650,14651,14652,14653,14654,14655,14656,14657,14658,14659,14661,14662,14663,14664,14665,14667,14668,14669,14670,14671,14673,14674,14675,14676,14678,14679,14680,14683,14685,14686,14687,14688,14690,14691,14693,14696,14697,14698,14699,14701,14704,14706,14708,14709,14711,14712,14714,14715,14717,14719,14720,14721,14722,14723,14724,14725,14729,14731,14732,14733,14736,14737,14739,14740,14742,14743,14744,14745,14746,14747,14748,14749,14750,14753,14754,14756,14757,14759,14760,14761,14762,14763,14764,14765,14766,14767,14768,14770,14771,14773,14774,14775,14776,14777,14778,14779,14780,14782,14783,14785,14786,14787,14788,14789,14790,14791,14792,14793,14794,14795,14796,14797,14798,14799,14800,14801,14802,14803,14804,14806,14807,14808,14809,14810,14811,14812,14813,14815,14816,14819,14820,14821,14823,14826,14828,14829,14831,14832,14833,14834,14835,14837,14838,14839,14842,14843,14844,14845,14846,14847,14848,14849,14850,14851,14852,14853,14854,14855,14856,14857,14859,14860,14863,14864,14865,14867,14868,14869,14870,14871,14872,14873,14874,14875,14876,14878,14880,14881,14882,14883,14884,14885,14886,14888,14889,14890,14891,14892,14893,14894,14895,14896,14897,14898,14899,14900,14901,14902,14903,14904,14905,14906,14907,14908,14909,14910,14911,14912,14913,14914,14915,14916,14918,14919,14920,14922,14923,14924,14925,14927,14928,14931,14933,14934,14935,14937,14938,14941,14943,14944,14945,14946,14948,14949,14950,14951,14952,14953,14954,14955,14956,14957,14958,14959,14960,14961,14965,14966,14971,14972,14973,14974,14975,14976,14977,14979,14981,14982,14983,14984,14985,14986,14987,14988,14989,14990,14991,14992,14993,14994,14995,14996,14997,14999,15000,15001,15003,15004,15005,15007,15009,15010,15011,15013,15016,15018,15019,15023,15025,15026,15027,15028,15029,15030,15031,15032,15033,15035,15036,15040,15043,15044,15153,15154,15155,15156,15157,15158,15159,15160,15161,15162,15163,15164,15165,15166,15167,15168,15169,15170,15171,15172,15173,15174,15175,15176,15177,15178,15179,15180,15181,15182,15183,15185,15186,15188,15189,15196,15198,15199,15201,15203,15204,15207,15208,15209,15210,15211,15212,15213,15214,15215,15216,15222,15223,15224,15226,15228,15229,15230,15231,15254,15255,15256,15259,15260,15261,15263,15273,15274,15275,15276,15278,15279,15280,15283,15284,15288,15289,15290,15291,15292,15293,15294,15315,15316,15317,15320,15321,15322,15325,15326,15328,15330,15331,15332,15333,15334,15335, 15336,15338,15339,15340,15341,15343,15344,15347,15348,15349,15350,55525,55529,55533,10032,10175, 10192,10361,10372,10449, 10192, 10266,10356, 10372, 10449, 10690, 11016, 11167, 11229, 11320, 11611, 11618,11682,11683,11688,11698,11712,11763,11783,11792,11811,11815,11820,11825,11849,11853,11855,11860,11871,11872,11894,11895,11908,11909,11910,11914,11915,11921,11922,12062,12063,12064,12065,12113,12116,12134,12143,12148,12149,12150,12151,12161,12165,12166,12168,12214,12221,12238,12245,12246,12247,12267,12300,12301,12307,12308,12319,12320,12358,12365,12367,12374,12381,12385,12390,12427,12448,12449,12506,12507,12509,12515,12519,12525,12529,12560,12564,12566,12571,12572,12576,12585,12590,12593,12608,12609,12616,12637,12659,12660,12661,12666,12714,12739,12749,12750,12751,12754,12755,12758,12759,12760,12764,12787,12799,12804,12811,12812,12824,12841,12842,12876,12912,12914,12915,12921,12924,12933,12934,12936,12946,12951,12952,12954,12955,12959,12981,12989,12990,12991,12995,12998,13001,13006,13012,13021,13030,13032,13033,13038,13048,13049,13100,13106,13108,13111,13112,13124,13140,13141,13143,13145,13146,13147,13161,13162,13172,13187,13222,13235,13236,13237,13243,13247,13248,13276,13300,13311,13335,13352,13357,13358,13361,13372,13380,13383,13384,13388,13390,13398,13414,13419,13422,13424,13432,13433,13434,13446,13457,13468,13503,13504,13505,13506,13551,13559,13565,13583,13615,13620,13623,13630,13631,13632,13635,13646,13647,13650,13660,13662,13663,13665,13683,13699,13719,13720,13738,13740,13795,13807,13813,13815,13839,13854,13855,13860,13861,13865,13866,13873,13882,13885,13889,13890,13891,13898,13922,13924,13956,13960,13961,13973,13975,13979,13981,13985,13994,13996,14001,14002,14003,14051,14052,14053,14057,14060,14066,14067,140802,14092,14093,14094,14099,14104,14112,14116,14124,14143,14145,14155,14156,14160, 14161,14169,14171,14172,14173,14199,14200,14220,14222,14251,14252,14253,14273,14280,14281,14283, 14292,14294,14308,14310,14371,14372,14387,14397,14480,14624,14666,14677,14682,14694,14695,14702,14707,14710,14726,14727,14728,14730,14741,14769,14781,14784,14805,14814,14817,14818,14824,14827,14840,14926,14930,14932,14940,14967,14970,15002,15008,15015,15017,15020,15038,15039,15184,15187,15193,15194,15195,15197,15205,15206,15218,15219,15220,15221,15227,15281,15287,15295,15296,15297,15298,15299,15345,41968,41980,55553 & 72762.
• Recalling Firm/ Manufacturer: Philips Medical Systems (Cleveland) Inc; 595 Miner Rd; Cleveland OH 44143-2131
• For Additional Information Contact: Kumudini J. Carter; 440-483-3032
• Manufacturer Reason for Recall: Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
• FDA Determined Cause: Software design
• Action: Philips Healthcare sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. This Field Safety notification is to inform the actions that should be taken by the customer/user to prevent risks for patient or users, and the actions planned by Philips to correct the problem. If you need further information or supplies please contact your local Philips Healthcare office. For North American and Canada contact the Customer Care Solutions Center ( 1-800 722-9377) option 5 enter site or follow the prompts.
• Quantity in Commerce: 2,580 units
• Distribution: Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.
• 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 = ELSCINT, INC.