Rappel de Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64259
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0906-2013
  • Date de publication de l'événement
    2013-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2013-12-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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

  • Modèle / numéro de série
    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, 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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
  • Source
    USFDA