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Recall Observatory FDA recall evidence

Device product

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

Z-2283-2023

June 12, 2023

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 92635
Status
Ongoing
Classification
Class II
Quantity
648 units
Official record key
device-enforcement:Z-2283-2023

Official wording

Reason: The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.