Device Recall Integris Allura

All serial numbers

Radiology Devices

2

No

Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

INTEGRIS Allura 9 (biplane); Model Number: 722021 || The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions

All serial numbers

Radiology Devices

2

No

Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Democratic Congo, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

INTEGRIS Allura 15-12 (mono); Model Number: 722043 || The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura 12 & 15 system is intended for peripheral, abdominal, cerebral diagnostic and interventional angiography, neuro applications, cardiac applications and non-vascular interventions

site numbers provided in the product listing for Z-0366-2007

Radiology Devices

2

No

Units were distributed to hospitals and medical centers nationwide.

FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10' and 20' detectors

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.

Radiology Devices

2

No

Worldwide Distribution

Integris Allura Flat Detector 9C