—#97392

Product

Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K984545
Affected lot / code info: 10104, 10107, 10166, 10277, 10288, 10313, 10325, 10329, 10390, 10391, 10403, 10414, 10430, 10431, 10439, 10442, 10454, 10463, 10465, 10478, 10482, 10495, 13043, 13106, 13107, 13108, 13113, 13114, 13117, 13230, 13240, 13259, 13290, 13292, 13294, 13296, 13511, 13530, 13595, 13596, 13631, 13633, 13688, 13719, 13720, 13734, 13883, 13890, 13891, 13915, 13941, 13953, 13954, 13980, 13990, 13992, 13993, 13994, 14021, 14068, 14145, 14168, 17476, 17500, 17504, 17596, 17599, 25973, 25974, 26007, 26064, 26072, 26109, 26118, 26158, 26159, 26161, 26166, 26179, 26217, 26218, 26264, 26286, 26288, 26289, 26293, 26295, 35427, 35463, 35485, 35591, 37908, 37923, 37970, 38062, 38109, 38110, 38182, 38199, 38201, 38203, 38204, 38205, 38261, 38276, 38290, 38298, 38329, 38352, 38355, 38356, 38359, 38373, 38385, 38386, 38387, 38389, 38425, 38426, 38437, 38531, 38533, 38554, 38592, 38637, 38681, 38702, 38703, 38704, 38705, 38718, 38719, 38728, 38754, 38788, 38789, 38790, 38792, 38795, 38903, 38926, 38932, 38933, 38935, 38948, 40390, 40938, 41017, 41019, 41021, 41026, 41027, 41050, 41079, 41080, 41103, 41104, 41109, 41115, 41117, 41128, 41129, 41137, 41141, 41142, 41145, 41151, 41152, 41154, 41163, 41164, 41222, 41242, 41266, 41267, 41269, 41272, 41273, 41330, 41336, 41340, 41341, 41423, 41455, 41458, 41478, 41479, 44609, 44712, 44714, 44752, 44774, 44779, 44784, 44825, 44854, 44857, 44860, 44966, 44973, 44978, 45000, 45026, 45045, 45047, 45051, 45059, 45072, 45104, 47106, 47127, 47138, 47139, 50222, 50223, 50224, 50310, 50311, 50312, 50332, 50335, 50339, 50345, 50371, 50373, 50374, 50375, 50389, 50392, 50405, 50419, 50433, 52451, 52464, 52465, 52466, 52470, 52477, 52479, 52480, 52482, 52488, 59366, 59390, 59418, 59422, 59501, 59520, 59552, 59610, 59611, 59659, 59698, 59699, 59709, 62493, 62508, 62519, 62528, 62531, 62544, 62559, 62606, 62627, 62639, 62668, 62670, 62671, 62775, 62776, 62779, 62785, 62787, 62792, 62805, 62833, 62835, 62871, 62892, 62921, 62942, 62948, 62951, 62967, 62968, 62969, 62976, 62998, 62999, 68154, 68156, 68168, 68211, 68214, 74080, 76198, 76214, 76219, 76325, 76360, 76365, 76378, 76380, 76397, 76398, 76411, 76455, 76459, 76462, 76465, 76471, 76484, 76486, 76489, 76490, 76499, 76500, 76505, 76510, 76514, 76520, 76521, 76522, 76527, 76545, 76546, 76555, 76557, 76558, 76559, 76560, 76572, 76574, 76576, 76577, 76580, 76830, 76831, 76832, 76867, 76870, 76872, 76873, 76885, 76886, 76933, 76941, 76953, 76955, 76962, 76986, 80305, 80310, 80315, 80320, 80322, 80323, 80325, 80330, 82514, 82517, 82519, 82520, 82521, 82523, 82526, 82539, 82542, 82543, 82575, 82576, 82577, 82591, 82592, 82593, 82608, 82609, 82612, 82615, 82633, 82635, 82637, 82640, 82643, 82661, 82663, 82664, 82665, 82676, 82691, 82696, 82699, 82706, 82709, 82719, 82814, 82822, 82824, 82825, 82909, 82915, 82916, 82917, 82950, 83019, 83024, 83026, 83028, 83040, 83042, 83054, 83081, 83309, 83310, 83313, 83322, 83324, 83326, 83327, 83375, 83399, 83605, 83632, 83663, 83664, 83665, 83667, 83670, 83807, 83823, 83833, 83834, 83838, 83842, 83855, 83862, 83882, 83903, 83904, 83924, 83926, 83927, 83949, 83996, 84378, 84430, 84431, 84436, 84443, 84444, 84445, 84447, 84466, 84467, 84481, 84482, 84487, 84489, 84713, 84716, 84721, 84734, 84791, 84823, 84826, 84827, 84828, 84829, 84838, 84843, 84998, 85004, 85008, 85010, 85013, 85015, 85018, 85041, 85054, 85057, 85058, 85087, 85092, 85093, 85094, 85095, 85096, 85106, 85107, 85126, 85128, 85129, 85130, 85133, 85135, 85137, 85150, 85169, 85179, 85190, 85195, 85197, 85409, 85415, 85416, 85447, 85488, 85497, 85498, 85499, 85501, 85503, 85633, 85634, 85635, 85637, 85638, 85639, 85640, 85641, 85643, 85676, 85689, 85692, 86057, 86061, 86063, 86065, 86087, 86088, 86126, 86129, 86135, 86144, 86145, 86149, 86169, 86171, 86172, 86183, 86189, 86252, 86253, 86272, 86289, 86295, 86296, 86319, 86320, 86322, 86332, 86341, 86360, 86367, 86415, 86419, 86421, 86424, 86427, 86429, 86431, 86433, 86435, 86437, 86456, 86488, 86494, 86495, 86502, 86506, 86537, 86539, 86540, 86561, 86571, 86572, 86575, 86576, 86577, 86578, 86580, 86581, 86583, 86584, 86598, 86603, 86933, 86934, 86935, 86953, 86971, 86972, 86981, 86982, 86991, 86992, 86993, 86994, 87013, 87023, 87024, 87055, 87068, 87069, 87084, 87179, 87300, 87315, 87316, 87317, 87318, 87324, 87339, 87359, 87364, 87366, 87528, 87530, 87532, 87603, 91650, 100262, 100316, 100319, 100328, 100432, 100434, 100450, 100470, 100475, 100477, 100496, 100504, 100519, 100521, 100522, 100585, 100587, 100607, 100610, 100613, 100630, 100631, 100641, 100643, 100645, 100656, 100658, 100685, 100701, 100704, 100708, 100713, 100714, 100744, 100783, 100788, 100810, 100811, 100812, 100823, 100839, 100840, 100841, 100861, 100862, 100863, 100864, 100865, 100866, 100869, 100875, 100881, 100913, 100945, 100948, 100949, 100950, 100959, 100961, 101000, 101006, 101036, 101040, 101073, 101077, 101078, 101110, 101135, 101136, 101160, 101208, 101216, 101238, 101239, 101309, 101433, 101434, 101485, 101564, 101565, 101566, 101567, 101577, 101582, 101583, 101589, 101593, 101606, 101607, 101609, 101610, 101612, 101613, 101615, 101617, 101618, 101619, 101620, 101928, 101938, 101941, 101945, 101949, 101965, 101971, 101973, 101974, 102000, 102001, 102009, 102037, 102039, 102083, 102094, 102103, 102158, 102160, 102161, 102162, 102179, 102180, 102193, 102243, 102248, 102334, 102348, 102487, 102493, 102502, 102521, 102523, 102555, 102558, 102572, 102575, 102589, 102629, 102631, 102632, 102650, 102661, 102664, 102673, 102675, 102676, 102677, 102710, 102715, 102723, 102746, 102785, 102793, 102809, 102817, 102823, 102842, 102863, 102868, 102870, 102874, 102908, 102936, 102937, 102944, 102945, 102949, 102953, 102974, 102983, 102995, 103002, 103004, 103005, 103021, 103022, 103026, 103029, 103034, 103063, 103070, 103133, 103144, 103147, 103148, 103169, 103170, 103182, 103183, 103193, 103201, 103211, 103212, 103213, 103214, 103231, 103237, 103238, 103240, 103241, 103246, 103248, 103255, 103257, 103266, 103270, 103287, 103290, 103327, 103335, 103355, 103356, 103371, 103379, 103380, 103382, 103420, 103446, 103447, 103448, 103456, 103481, 103494, 103512, 103518, 103520, 103557, 103581, 103587, 103594, 103599, 103650, 103709, 103712, 103714, 103721, 103722, 103743, 103746, 103763, 103776, 103793, 103812, 103819, 103823, 103828, 103829, 103830, 103831, 103860, 103879, 103891, 103900, 103901, 103926, 103929, 103957, 103991, 104021, 104033, 104056, 104057, 104062, 104076, 104107, 104111, 104145, 104148, 104169, 104170, 104177, 104187, 104194, 104198, 104335, 104337, 104341, 104382, 104383, 104384, 104385, 104386, 104402, 104403, 104411, 104412, 104413, 104414, 104415, 104418, 104424, 104426, 104427, 104440, 104441, 104463, 104511, 104513, 104516, 104529, 104539, 104580, 104581, 104627, 104630, 104797, 104799, 104865, 104884, 104885, 104909, 104933, 104941, 104943, 104974, 104976, 105098, 105153, 105243, 105254, 105299, 105305, 105309, 105389, 105399, 105404, 105422, 105489, 105511, 105514, 105583, 105703, 105731, 105733, 105736, 105737, 105773, 250005, 250042, 250046, 250071, 250073, 250083, 250084, 250146, 250149, 250298, 250299, 250300, 250333, 250338, 250454, 250477, 250531, 250550, 250581, 504530, 504536, 504742, 504904, 505249, 505707, 506655, 519846, 520720, 521359, 522511, 532078, 535601, 542459, 545636, 557639, 557726, 557740, 557746, 557761, 557762, 557770, 557772, 557773, 557778, 557780, 557795, 557802, 557810, 557834, 557839, 557840, 557841, 557842, 557864, 557866, 557890, 557907, 557926, 557934, 557937, 557939, 557957, 557974, 557984, 557986, 557997, 558005, 558021, 558028, 558029, 558030, 558032, 558036, 558037, 558070, 558121, 558122, 558145, 558148, 558149, 558167, 558168, 558169, 558178, 558180, 558182, 558183, 558187, 558192, 558198, 558199, 558261, 558265, 558268, 558271, 558278, 558286, 558287, 558299, 558323, 558350, 558378, 558383, 41445486, 41701751, 41726451, 43568695, 49788214, 49788949, 49788952, 49789163, 49789164, 49794087, 49794089, 49794485, 49794687, 49794702, 51324694, 51324699, 51324716, and 51324768.

Why it was recalled

A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 10/15/2010, Philips began sending out the URGENT-Device Correction Notice Failure Causing the Generator to Stop Working notification letter to their consignees. The consignees were informed that a short circuit may occur due to a faulty wire connection in the Supervisor Box Connector in the Generator, and it will cause the generator stops working. When the system fails during a critical interventional case, this may cause risk to patients (no Fluoro available). The systems involved in this recall are Allura Xper with the Velara Generator, Allura Integris with OMCP Generator, MultiDiagnost Eleva, and OmniDiagnost Eleva Imaging system. Consignees can contact Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 70800114, 70800115, 72200184, and 72200185.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Devices were distributed through out the US.

Timeline

Recall initiated: 2010-10-07
Posted by FDA: 2011-03-16
Terminated: 2012-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97392. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.