Allura Xper FD10 and FD20. X-ray Imaging System recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No.: 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035; UDI-DI: (01)00884838054189(21), (01)00884838054202(21), (01)00884838054240(21), (01)00884838059054(21), (01)00884838059085(21), (01)00884838059191(10), (01)00884838059283(10); System Equipment Number: 52756450, 53152280, 53339159, 53341109, 53362649, 53367108, 53417434, 53499745, 53532256, 53544735, 53564038, 53758475, 53760903, 53861955, 53882172, 53925133, 53953857, 53954111, 53977885, 54228786, 54367887, 54439862, 54439913, 54635472, 54650173, 54650176, 54803862, 54812217, 54853203, 54861346, 54877925, 54972306, 55063750, 55102809, 55103418, 55126283, 55137722, 55139337, 55236546, 55270907, 55289325, 55310609, 55366802, 55378038, 55379838, 55416634, 55423934, 55424653, 55431632, 55432120, 55624201, 55651562, 55835022, 56012278, 56034732, 56077694, 56131358, 56282614, 56310022, 56552489, 56711453, 56787342, 56889792, 56898414, 56898439, 56919586, 56925642, 56931775, 56932067, 56933642, 56983248, 57319691, 57348951, 57357341, 57379873, 57386323, 57396363, 57444596, 57452649, 57578907, 57630281, 57684134, 58022670, 58022730, 58022864, 58022921, 58033118, 58054630, 58196148, 58321891, 58390220, 58513734, 58728847, 58733704, 58733847, 58741381, 58749542, 58764500, 58772499, 58784562, 58795259, 58800293, 58815099, 58855513, 59061101, 59090230, 59094523, 59221685, 59354254, 59379544, 59424782, 59425858, 59446181, 59465072, 59480598, 59625660, 59704835, 59817779, 60047413, 60079553, 60081722, 60090524, 60171011, 60198772, 60294314, 60297658, 60318299, 60321582, 60327092, 60328979, 60330052, 60354769, 60373773, 60499643, 60557573, 60635087, 60829200, 60831976, 60842124, 60904932, 60991137, 61016297, 61043370, 61071047, 61099178, 61112173, 61112176, 61266903, 61371745, 61375420, 61394687, 61398352, 61398387, 61546505, 61547305, 61608254, 61629090, 61661597, 61814332, 61936802, 61949367, 62159620, 62198638, 62427661, 62427664, 62450325, 62492210, 62544255, 62545899, 62573656, 62657035, 62668027, 62670706, 62719278, 62733187, 62736188, 62755996, 62757810, 62791270, 62804392, 62809620, 62865500, 62923550, 62957886, 62979351, 62993713, 63017922, 63018226, 63047998, 63077672, 63098476, 63121356, 63175760, 63194056, 63194059, 63212800, 63253843, 63286707, 63303929, 63304196, 63326565, 63333557, 63452123, 63474399, 63491567, 63516113, 63549852, 63602056, 63853791, 63855069, 63856210, 63856215, 63863037, 63865903, 63866391, 63870144, 63890723, 63928782, 63952281, 63984549, 64008838, 64011215, 64063933, 64077887, 64103560, 64123525, 64123693, 64123696, 64123702, 64123703, 64180514, 64402898, 64410300, 64461457, 64491042, 64527844, 64554741, 64595916, 64647989, 64650352, 64650811, 64706311, 64765100, 64766806, 64822761, 64844581, 64853069, 64854463, 64901418, 64901706, 64903822, 64908711, 64910118, 64910488, 64924269, 64924683, 64925945, 64925949, 64926947, 64927462, 64933396, 64936762, 64937306, 64968987, 65001743, 65036864, 65172779, 65244430, 65262000, 65331685, 65331690, 65345691, 65574300, 65585306, 65586654, 65612700, 65646912, 65786932, 65871006, 65874081, 65924446, 66060894, 66066456, 66113026, 66201842, 66269318, 66269328, 66279671, 66307999, 66317801, 66402080, 66406202, 66411234, 66491359, 66627732, 66696171, 66697417, 66698299, 66698300, 66721418, 66736708, 66760930, 66872804, 66884009, 67083620, 67141744, 67204960, 67216484, 67223745, 67386591, 67387066, 67475814, 67476532, 67578979, 67710106, 67710110, 67727326, 67728077, 67734686, 67751403, 67751516, 67903748, 67914456, 67939478, 67942241, 67965327, 67983947, 68003424, 68022280, 68029939, 68037595, 68041315, 68042085, 68060953, 68061145, 68061282, 68199187, 68209734, 68232390, 68330357, 68389185, 68418947, 68439154, 68472776, 68498163, 68556453, 68632801, 68641011, 68669027, 68733944, 68797548, 68899514, 68901092, 68903915, 68914214, 68915301, 68980613, 69271659, 69278037, 69366751, 69394758, 69441410, 69460177, 69489849, 69528963, 69530656, 69559144, 69670373, 69774386, 69858034, 69889192, 70020657, 70075365, 70094640, 70219301, 70233107, 70254598, 70284959, 70303747, 70544595, 70573139, 70682228, 70801806, 70849480, 71044357, 71074937, 71094183, 71144363, 71155256, 71614910, 71876533, 71900384, 71918189, 71925061, 71928815, 71994534, 72157698, 72418941, 72419941, 72504420, 72566416, 72790888, 72790987, 72805832, 72869665, 72887766, 73110425, 73127303, 73304271, 73304321, 73334786, 73423267, 73599337, 73599398, 73628021, 73644457, 73816785, 73983420, 74605020, 74609617, 74620297, 74840232, 74851569, 75023551, 75233375, 75429888, 75529932, 75591302, 75627264, 75868489, 76888120, 77022165, 78105118, 79025103, 79080763, 79109100, 79137359, 79441089, 80098525, 80098649, 80142771, 80148881, 80667406, 81230876, 81251376, 81283774, 81285503, 81290654, 81628184, 81640393, 82020210, 82253075, 82376216, 83257913, 83589700, 85763501, 88705553.

Product

Allura Xper FD10 and FD20. X-ray Imaging System.

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Quantity

648 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.

Recall date

August 9, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)