Retiro De Equipo (Recall) de Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Philips Medical Systems (Cleveland) Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64259
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0906-2013
  • Fecha de publicación del evento
    2013-03-05
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    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.
  • Acción
    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

  • Modelo / 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, 13971,13972,13974,13976,13977,13978,13980,13982,13983,13984,13986,13987,13988,13989,13990,13992,13993,13995,13997,13998,13998,13999,14000,14005,14006,14007,14008,14009,14010,14011,14012,14013,14014,14015,14016,14017,14018,14019,14020,14021,14022,14023,14024,14025,14026,14027,14028,14029,14030,14031,14032,14033,14034,14035,14036,14037,14038,14039,14040,14050,14054,14055,14058,14059,14061,14062,14063,14064,14065,14068,14069,14070,14071,14072,14073,14074,14075,14076,14077,14078,14079,14080,14081,14082,14083,14084,14085,14086,14087,14088,14089,14090,14091,14095,14096,14097,14098,14100,14101,14102,14103,14105,14106,14107,14108,14109,14110,14111,14113,14114,14115,14117,14118,14119,14120,14121,14122,14123,14125,14126,14129,14130,14131,14132,14133,14135,14136,14137,14138,14139,14140,14141,14142,14147,14148,14149,14152,14157,14158,14159,14162,14163,14164,14165,14167,14170,14174,14219,14221,14223,14224,14248,14250,14254,14255,14256,14257,14258,14259,14260,14261,14262,14263,14264,14265,14266,14267,14268,14269,14269,14270,14271,14274,14275,14276,14277,14278,14279,14282,14284,14285,14286,14287,14288,14289,14290,14291,14293,14295,14296,14297,14298,14299,14300,14301,14302,14303,14304,14305,14306,14307,14309,14311,14313,14314,14315,14316,1431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10192,10361,10372,10449, 10192, 10266,10356, 10372, 10449, 10690, 11016, 11167, 11229, 11320, 11611, 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& 72762.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

  • Dirección del fabricante
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA