Z-2283-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- June 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 648 units
Product Description
Allura Xper FD10 and FD20. X-ray Imaging System.
Reason for Recall
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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.
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.