| Class 2 Device Recall Integris Allura Flat Detector 9C | |
Date Initiated by Firm | December 10, 2008 |
Date Posted | September 24, 2009 |
Recall Status1 |
Terminated 3 on August 17, 2012 |
Recall Number | Z-0350-2009 |
Recall Event ID |
50742 |
510(K)Number | K022899 |
Product Classification |
Angiographic X-Ray System - Product Code IZI
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Product | Integris Allura Flat Detector 9C |
Code Information |
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. |
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 2 | 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 | 449 units |
Distribution | Worldwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = IZI
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