Class 2 Device Recall Integris H5000F

• Date Initiated by Firm: December 10, 2008
• Date Posted: September 24, 2009
• Recall Status: Terminated on August 17, 2012
• Recall Number: Z-0345-2009
• Recall Event ID: 50742
• 510(K)Number: K984545
• Product Classification: Angiographic X-Ray System - Product Code IZI
• Product: Integris H5000F
• Code Information: FCO # 72200108 - 1st phase, FCO#72200137 or 72200140 or 72200138 or 72200141 Equipment #'s 100865, 101952, 102564, 102730, 102923, 103275, 103289, 103525, 103696, 103729, 103751, 103875, 103927, 104060, 104106, 104139, 104512, 104536, 104668, 104859, 104927, 105073, 105100, 105137, 105139, 105153, 105156, 105304, 105343, 105386, 105409, 105411, 105582, 105583, 105631, 105684, 105742, 105866, 105908, 105917, 105950, 105951, 105952, 105953, 105961, 500004, 500041, 500052, 504344, 504636, 504638, 504646, 504769, 504776, 504795, 504871, 504904, 504908, 504920, 504977, 504988, 505008, 505017, 505064, 505111, 505135, 505250, 505252, 505270, 505271, 505363, 505421, 505424, 505453, 505520, 505546, 505650, 505680, 505706, 505803, 505804, 505807, 505886, 506009, 506048, 506060, 506121, 506222, 506225, 506369, 506462, 506469, 506541, 506693, 519179, 519199, 519212, 519536, 519673, 519676, 519767, 519868, 519874, 520147, 520189, 520517, 520526, 520840, 521224, 521310, 521313, 521562, 521918, 522224, 530464, 530466, 530655, 530656, 530658, 530668, 532148, 532172, 532234, 532653, 533394, 533541, 533567, 534041, 534155, 534159, 534252, 534627, 534879, 535012, 535091, 535348, 535387, 535777, 537731, 538537, 539507, 540468, 542459, 547283, 555055, and 44536044. Additional Eqiupment #s for Phase 2 - 10104, 10166, 10277, 10288, 10313, 10325, 10390, 10391, 10403, 10414, 10430, 10431, 10439, 10442, 10454, 10463, 10464, 10465, 10478, 10482, 10495, 13043, 13044, 13093, 13106, 13108, 13113, 13114, 13117, 13230, 13240, 13242, 13259, 13289, 13296, 13530, 13595, 13627, 13631, 13683, 13685, 13688, 13719, 13720, 13731, 13734, 13743, 13756, 13863, 13883, 13890, 13891, 13915, 13941, 13953, 13980, 13990, 13994, 14068, 14168, 17488, 17497, 17504, 17596, 17598, 17599, 25973, 26069, 26072, 26073, 26076, 26109, 26118, 26137, 26158, 26159, 26179, 26217, 26264, 26286, 26288, 26289, 26293, 26295, 35411, 35427, 35436, 35447, 35463, 35505, 37923, 37964, 37970, 37988, 38110, 38181, 38182, 38199, 38201, 38203, 38204, 38205, 38261, 38276, 38290, 38298, 38336, 38352, 38355, 38359, 38373, 38385, 38386, 38387, 38389, 38425, 38437, 38531, 38533, 38554, 38592, 38637, 38642, 38681, 38702, 38703, 38704, 38705, 38718, 38719, 38728, 38733, 38754, 38788, 38789, 38795, 38903, 38916, 38918, 38919, 38926, 38932, 38934, 38935, 38937, 38948, 38949, 38964, 38986, 40389, 40390, 40938, 41017, 41018, 41019, 41021, 41026, 41027, 41079, 41103, 41104, 41109, 41117, 41128, 41137, 41141, 41142, 41145, 41151, 41152, 41153, 41154, 41163, 41164, 41221, 41222, 41224, 41242, 41266, 41267, 41269, 41273, 41328, 41329, 41330, 41335, 41336, 41341, 41405, 41406, 41409, 41425, 41430, 41478, 41479, 41480, 44609, 44712, 44752, 44763, 44774, 44779, 44784, 44825, 44842, 44857, 44860, 44966, 44973, 44978, 45000, 45026, 45045, 45047, 45051, 45058, 45059, 45060, 45072, 45104, 47047, 47110, 47138, 47139, 47190, 50222, 50224, 50305, 50306, 50310, 50311, 50312, 50332, 50335, 50339, 50345, 50371, 50373, 50374, 50389, 50405, 50433, 52451, 52464, 52466, 52476, 52477, 52479, 52480, 52482, 52485, 59366, 59501, 59520, 59548, 59551, 59552, 59610, 59611, 59659, 59698, 59699, 59703, 59709, 59710, 62493, 62524, 62528, 62544, 62557, 62627, 62638, 62639, 62668, 62670, 62770, 62785, 62787, 62804, 62805, 62833, 62834, 62835, 62871, 62892, 62921, 62940, 62942, 62948, 62951, 62969, 62975, 62976, 62999, 68154, 68156, 68168, 68211, 68214, 68231, 68254, 74080, 76214, 76219, 76324, 76325, 76327, 76328, 76343, 76360, 76380, 76397, 76398, 76411, 76445, 76455, 76459, 76462, 76463, 76465, 76471, 76484, 76486, 76499, 76500, 76505, 76510, 76514, 76521, 76522, 76527, 76528, 76545, 76546, 76555, 76557, 76558, 76559, 76574, 76576, 76577, 76817, 76830, 76831, 76832, 76870, 76872, 76873, 76883, 76884, 76885, 76886, 76895, 76933, 76962, 76987, 76995, 80305, 80310, 80315, 80323, 80325, 80330, 82514, 82517, 82520, 82523, 82526, 82539, 82542, 82543, 82575, 82576, 82577, 82591, 82592, 82593, 82612, 82615, 82633, 82635, 82637, 82639, 82640, 82642, 82643, 82661, 82664, 82665, 82676, 82691, 82692, 82696, 82699, 82706, 82711, 82719, 82814, 82815, 82822, 82824, 82825, 82909, 82915, 82916, 82917, 82950, 83016, 83019, 83024, 83026, 83028, 83040, 83042, 83054, 83081, 83309, 83310, 83313, 83322, 83324, 83326, 83375, 83399, 83605, 83607, 83632, 83659, 83663, 83664, 83665, 83667, 83670, 83807, 83821, 83822, 83833, 83838, 83842, 83855, 83861, 83862, 83882, 83903, 83904, 83924, 83926, 83949, 83994, 83996, 84378, 84430, 84431, 84436, 84443, 84445, 84447, 84466, 84467, 84481, 84482, 84713, 84714, 84716, 84790, 84791, 84823, 84826, 84828, 84829, 84838, 84843, 84998, 85004, 85008, 85010, 85011, 85014, 85015, 85054, 85057, 85058, 85087, 85092, 85096, 85106, 85107, 85129, 85131, 85133, 85135, 85169, 85179, 85195, 85197, 85409, 85415, 85416, 85447, 85488, 85498, 85499, 85501, 85503, 85633, 85635, 85637, 85638, 85639, 85640, 85641, 85643, 85676, 85678, 85689, 86057, 86063, 86088, 86126, 86129, 86135, 86145, 86149, 86169, 86170, 86171, 86172, 86183, 86189, 86252, 86253, 86289, 86295, 86296, 86341, 86367, 86420, 86421, 86422, 86424, 86427, 86429, 86431, 86433, 86437, 86488, 86495, 86502, 86505, 86506, 86537, 86539, 86540, 86561, 86571, 86576, 86577, 86578, 86580, 86581, 86598, 86603, 86934, 86935, 86953, 86972, 86981, 86982, 86990, 86991, 86993, 86994, 87004, 87023, 87024, 87055, 87069, 87084, 87179, 87187, 87300, 87315, 87316, 87319, 87324, 87334, 87337, 87364, 87366, 87528, 87530, 87532, 87603, 91650, 100195, 100262, 100319, 100327, 100432, 100450, 100477, 100496, 100504, 100519, 100522, 100607, 100610, 100630, 100631, 100656, 100685, 100697, 100744, 100823, 100839, 100840, 100841, 100861, 100862, 100863, 100864, 100869, 100875, 100881, 100949, 100950, 100959, 100961, 101000, 101006, 101037, 101040, 101077, 101078, 101135, 101136, 101160, 101208, 101216, 101238, 101239, 101564, 101565, 101567, 101571, 101575, 101577, 101582, 101583, 101593, 101612, 101613, 101615, 101617, 101618, 101928, 101938, 101941, 101945, 101971, 101974, 102032, 102039, 102098, 102158, 102162, 102180, 102193, 102243, 102248, 102334, 102348, 102487, 102521, 102555, 102558, 102572, 102575, 102589, 102631, 102635, 102650, 102661, 102664, 102673, 102677, 102723, 102778, 102785, 102793, 102810, 102817, 102823, 102855, 102856, 102868, 102871, 102872, 102936, 102945, 103005, 103063, 103132, 103133, 103150, 103169, 103212, 103213, 103237, 103240, 103241, 103266, 103270, 103290, 103327, 103336, 103371, 103446, 103447, 103448, 103456, 103481, 103512, 103519, 103520, 103535, 103557, 103587, 103594, 103599, 103650, 103656, 103721, 103746, 103763, 103776, 103793, 103812, 103819, 103829, 103830, 103831, 103860, 103879, 103891, 103900, 103926, 103929, 103991, 104033, 104062, 104076, 104169, 104170, 104177, 104187, 104383, 104384, 104385, 104402, 104410, 104413, 104414, 104418, 104423, 104440, 104441, 104513, 104539, 104541, 104580, 104581, 104627, 104753, 104799, 104865, 104884, 104885, 104943, 104974, 104976, 105098, 105299, 105308, 105309, 105389, 105404, 105422, 105514, 105703, 250042, 250046, 250298, 250299, 250338, 250454, 250477, 250550, 504912, 505249, 505567, 519846, 522511, 532078, 532212, 537613, 543761, 557744, 557746, 557772, 557778, 557780, 557795, 557802, 557834, 557840, 557842, 557864, 557866, 557890, 557907, 557926, 557934, 557937, 557939, 557946, 557958, 557962, 557974, 557975, 557976, 557984, 557986, 557997, 558000, 558005, 558021, 558029, 558030, 558032, 558036, 558037, 558070, 558121, 558122, 558145, 558149, 558167, 558168, 558169, 558178, 558182, 558187, 558261, 558265, 558268, 558271, 558278, 558286, 558299, 558323, 558350, 558378, 558383, 43568695, 49788949, 49788952, 49788982, 49789163, 49789164, 49794485, 49794687,and 49794702.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: 425-487-7602
• Manufacturer Reason for Recall: Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
• Quantity in Commerce: 929 units
• Distribution: Worldwide Distribution
• 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 = IZI