Z-0906-2013Class II
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended...
Philips North America LLC / initiated 2012-09-28 / Terminated / root cause: software
Philips Medical Systems (Cleveland) Inc began a recall of Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-0906-2013
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- 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.
- Product code
- JAK System, X-Ray, Tomography, Computed
- 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.
- Root cause tag
- software
- FDA root 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.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0906-2013 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.