PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10 and FD20. X-ray Imaging System.

Recall number

Z-2283-2023

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

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

Status

Open, Classified

Initiated

2023-06-12

Posted

2023-08-02

Terminated

not on file

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.

Root cause

Component design/selection

Action

Customers were mailed a recall notification dated 6/8/23 notifying them of this medical device correction. Customers are asked to retain the correction notice until all on-site are corrected, ensuring they are available to those who operate the device. If cracks in the FlexMove Carriage and/or abnormal noise during transversal movements of the C-Arc are observed, customers are to contact Philips so their field inspection may be prioritized. A diagram of crack locations on the FlexMove Carriage was provided for user reference. Customers are asked to return the provided Response Form no later than 30 days from receipt. Philips will contact customers to schedule a visit to inspect on-site systems and coordinate replacement of the affected bolts and/or FlexMove Carriage, as needed. Customers with any questions may contact Customer Care Solutions at 1-800-722-9377. Philips sent an updated notification to customers on 11/15/2024 with updated information regarding continued use and actions planned by Philips. Systems may be safely continuing to be sued for at least three (3) years after completing the inspectional activities described in the Correction and Removal Actions of the provided letter and Philips will contact customers to schedule a visit to install the permanent solution ensuring that it is implemented within 3 years after the initial inspectional activities or after installation. The permanent solution expected to be available by December 2024. Customers were also instructed to complete and return the Response Form.

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.

Lot, serial or model codes

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.

510(k) numbers

["K130638","K162859"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy