Recall of Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64259
  • Event Risk Class
    Class 2
  • Event Number
    Z-0906-2013
  • Event Date Posted
    2013-03-05
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-12-26
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    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.
  • 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.

Device

  • Model / Serial
    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, 11892,11893,11896,11897,11898,11899,11900,11901,11902,11903,11904,11905,11906,11907,11911, 11912,11913,11916,11917,11918,11920,11923,11925,11927,11928,11929,11930,11932,11933,11934, 11935,11936,11937,11938,11939,11942,11943,11944,11947,11976,11977,11978,11979,11980,12049, 12051,12100,12100,12102,12103,12104,12105,12106,12107,12108,12109,12110,12111,12112,12115, 12117,12118,12119,12120,12121,12122,12123,12124,12125,12126,12128,12129,12130,12132,12133, 12136,12138,12139,12140,12141,12142,12144,12145,12146,12147,12152,12154,12155,12157,12158, 12159,12160,12162,12163,12164,12167,12170,12171,12172,12173,12174,12175,12176,12178,12179, 12180,12181,12182,12183,12200,12201,12202,12203,12204,12205,12206,12207,12208,12209,12210, 12211,12215,12216,12217,12218,12219,12220,12222,12223,12224,12225,12226,12227,12228,12229, 12230,12231,12236,12237,12239,12240,12241,12242,12243,12244,12248,12249,12250,12271,12273, 12274,12302,12303,12304,12305,12306,12309,12310,12311,12312,12314,12315,12316,12317,12318, 12321,12322,12323,12324,12325,12326,12327,12328,12329,12330,12331,12332,12333,12336,12337, 12338,12339,12341,12342,12343,12345,12346,12347,12348,12349,12350,12351,12352,12353,12354, 12355,12356,12357,12359,12360,12362,12363,12364,12366,12369,12370,12373,12376,12377,12379, 12380,12382,12383,12386,12388,12389,12391,12392,12394,12396,12397,12398,12399,12400,12403, 12405,12406,12407,12408,12409,12410,12411,12412,12413,12414,12415,12416,12417,12418,12419, 12420,12421,12422,12423,12424,12425,12428,12429,12430,12431,12432,12434,12435,12436,12438, 12439,12440,12441,12443,12444,12445,12446,12447,12471,12472,12473,12474,12475,12476,12477, 12492,12493,12494,12495,12496,12497,12498,12500,12501,12503,12504,12505,12508,12510,12513, 12514,12516,12517,12521,12522,12526,12527,12528,12530,12531,12538,12539,12541,12542,12543, 12544,12545,12546,12547,12548,12549,12550,12551,12552,12553,12554,12555,12556,12557,12558, 12559,12561,12562,12563,12565,12567,12568,12569,12570,12573,12574,12575,12577,12579,12580, 12581,12583,12584,12586,12587,12588,12589,12591,12592,12594,12595,12596,12597,12598,12601, 12602,12603,12604,12605,12606,12611,12612,12614,12617,12618,12619,12620,12621,12622,12623, 12625,12626,12627,12628,12629,12631,12632,12633,12634,12636,12638,12640,12641,12643,12645, 12646,12647,12648,12649,12650,12651,12652,12653,12654,12656,12657,12658,12662,12663,12664, 12665,12669,12670,12671,12672,12673,12674,12675,12676,12677,12678,12679,12680,12681,12700, 12701,12702,12703,12704,12705,12706,12707,12708,12709,12710,12711,12712,12713,12716,12719, 12720,12722,12723,12724,12725,12726,12727,12730,12731,12732,12733,12734,12735,12740,12741, 12742,12743,12744,12745,12747,12748,12752,12753,12756,12757,12761,12763,12765,12767,12768, 12769,12770,12771,12772,12773,12774,12776,12777,12778,12780,12783,12784,12786,12791,12792, 12797,12800,12801,12802,12803,12805,12806,12807,12808,12809,12814,12817,12818,12819,12820, 12821,12822,12823,12826,12827,12828,12829,12830,12831,12832,12833,12834,12835,12836,12837, 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, 13910,13911,13912,13913,13914,13915,13916,13917,13918,13919,13920,13921,13923,13925,13926,13927,13928, 13930,13931,13950,13951,13952,13953,13954,13955,13957,13959,13962,13963,13966,13967,13968,13969,13970, 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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA