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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92635

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 12, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-2283-2023
Recall number
Z-2283-2023
Initiated
June 12, 2023
Classification
Class II
Status
Ongoing
Quantity
648 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 2 of 2

Azurion 7 M20. X-ray Image guided Therapy System.

Z-2284-2023
Recall number
Z-2284-2023
Initiated
June 12, 2023
Classification
Class II
Status
Ongoing
Quantity
648 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75852749, 75855479, 75935287, 76078970, 76091821, 76138290, 76417103, 76479323, 76515054, 76553358, 76577152, 76787680, 76891085, 77121963, 77427180, 77530081, 77654726, 77654982, 77777427, 77779946, 77970791, 77970948, 77992050, 78105115, 78248928, 78294148, 78301055, 78397953, 78566369, 78742461, 78871714, 78951530, 79075848, 79092310, 79109133, 79112403, 79170704, 79221166, 79260136, 79386139, 79721725, 79755150, 79871193, 80031529, 80162299, 80389257, 80518631, 80634403, 80757669, 80864517, 80909985, 81158245, 81198118, 81435812, 81576136, 81585676, 82061620, 82084127, 83171264, 83616043, 84187167, 84817818, 86188742, 86497093, 86714680, 86796686, 87030322, 87184700, 87490196, 88006565, 88182534, 88520522, 88806300, 89171879, 89418260, 91702038, 92145971, 92904015, 93089744, 93184693, 93338682, 93496319, 93571818, 93617781, 93640291, 94453083, 94693032, 95022475, 95133121, 95182889, 95492390, 95747223, 95747224, 96447199, 96449972, 97171402, 97171408, 97385374, 97640203, 98542276, 98862191, 99584876,

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.