Recalls / —

—#76850

Product

Integris Allura Flat Detector 9C

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K022899

Affected lot / code info

FCO 72200118 for 1st phase 72200132 for 2nd phase Equipment #'s 102560, 102948, 103128, 103265, 103331, 103561, 103562, 103564, 103780, 103781, 104075, 104149, 104464, 104501, 104514, 104515, 104642, 104670, 104890, 104925, 104952, 104954, 104955, 104956, 104957, 104958, 105081, 105082, 105136, 105140, 105157, 105186, 105191, 105390, 105402, 105598, 105615, 105655, 105656, 105674, 105779, 105784, 105912, 105940, 105946, 105947, 105960, 500028, 500029, 500038, 500042, 504493, 504659, 504665, 504666, 504730, 504750, 504770, 504789, 504792, 504797, 504798, 504806, 504807, 504872, 504913, 504915, 504916, 504940, 505106, 505107, 505281, 505486, 505538, 505572, 505587, 505651, 505668, 505679, 505707, 505719, 505759, 505805, 505809, 505861, 505925, 505989, 506047, 506049, 506148, 506169, 506170, 506178, 506230, 506232, 506322, 506370, 506397, 506403, 506408, 506476, 506538, 506564, 506616, 506621, 506637, 506654, 506657, 506658, 506785, 519115, 519198, 519211, 519213, 519214, 519533, 519534, 519535, 519537, 519541, 519548, 519576, 519594, 519677, 519680, 519733, 519738, 519771, 519812, 519899, 519901, 519989, 520004, 520236, 520251, 520309, 520430, 520431, 520481, 520523, 520524, 520525, 520680, 520681, 520761, 520809, 520882, 520956, 521131, 521223, 521318, 521320, 521463, 521537, 521545, 521650, 521661, 521711, 521763, 521769, 521770, 521802, 521853, 521854, 521892, 522038, 522065, 522118, 522119, 522135, 522162, 522177, 522191, 522243, 522245, 522247, 522250, 522293, 522418, 522440, 522446, 522458, 530361, 530370, 530390, 530421, 530459, 530460, 530463, 530662, 530669, 531651, 531753, 531805, 531806, 531813, 531837, 532074, 532080, 532178, 532215, 532246, 532292, 532445, 532534, 532535, 532612, 532613, 532615, 532616, 532617, 532652, 532986, 533085, 533236, 533286, 533343, 533401, 533418, 533619, 533796, 533861, 533922, 533967, 534160, 534218, 534221, 534233, 534237, 534251, 534268, 534427, 534440, 534476, 534477, 534478, 534479, 534630, 534681, 534717, 534743, 534758, 534813, 534874, 534876, 535224, 535250, 535342, 535614, 535728, 535979, 536090, 536425, 536639, 536777, 537020, 537065, 537644, 538269, 538763, 539099, 544478, 544479, 544502, 547870, and 553147   Addtional Equipment #s from phase 2 - 26161, 26166, 84444, 84489, 85013, 85041, 85093, 85094, 85126, 85128, 86061, 86065, 86144, 86272, 86319, 86320, 86322, 86332, 86360, 86435, 86456, 86494, 86501, 86572, 86575, 86583, 86933, 86971, 87013, 87318, 87339, 100316, 100328, 100434, 100470, 100475, 100521, 100585, 100587, 100613, 100643, 100645, 100658, 100701, 100704, 100714, 100783, 100788, 100810, 100811, 100866, 100913, 100945, 101036, 101073, 101309, 101433, 101434, 101485, 101566, 101589, 101609, 101610, 101619, 101620, 101864, 101965, 101973, 102000, 102001, 102009, 102037, 102083, 102094, 102103, 102160, 102161, 102179, 102493, 102502, 102629, 102632, 102675, 102676, 102710, 102715, 102746, 102791, 102842, 102863, 102870, 102874, 102944, 102953, 102983, 102995, 103002, 103004, 103021, 103022, 103026, 103029, 103034, 103070, 103148, 103170, 103182, 103183, 103193, 103201, 103211, 103214, 103238, 103246, 103248, 103255, 103257, 103335, 103355, 103356, 103379, 103382, 103494, 103518, 103709, 103712, 103714, 103743, 103823, 103828, 103906, 104057, 104107, 104111, 104145, 104148, 104194, 104198, 104337, 104382, 104403, 104411, 104412, 104415, 104424, 104426, 104427, 104463, 104511, 104516, 104529, 104630, 104631, 104797, 104909, 104933, 104941, 105243, 105254, 105305, 105489, 105511, 105731, 105733, 105736, 105737, 105773, 250005, 250071, 250084, 250300, 250333, 250581, 504530, 504536, 521359, 535601, 545636, 557810, 557839, 558192, 41726451, and 43234594.

Why it was recalled

Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Worldwide Distribution

Timeline

Recall initiated

2008-12-10

Posted by FDA

2009-09-24

Terminated

2012-08-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #76850. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.