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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93463

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

Open FDA event record

Event summary

Timeline bucket
August 29, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

Z-0611-2024
Recall number
Z-0611-2024
Initiated
August 29, 2023
Classification
Class II
Status
Ongoing
Quantity
83 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unintended movement of bed wheels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unintended movement of bed wheels

Code information

UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259

Distribution pattern

US: TN, CA, NY, IL, NV, PA, SD

device · product 2 of 2

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

Z-0612-2024
Recall number
Z-0612-2024
Initiated
August 29, 2023
Classification
Class II
Status
Ongoing
Quantity
846 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unintended movement of bed wheels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unintended movement of bed wheels

Code information

a) UDI/DI 050560973512, serial numbers: P0595355, P0595356, P0595357, P0595358, P0595359, P0595360, P0595361, P0595362, P0595363, P0595364, P0595365, P0595366, P0595367, P0595368, P0595369, P0595370, P0595371, P0595372, P0595373, P0595374, P0595375, P0595376, P0595377, P0595378, P0595379, P0595380, P0595381, P0595382, P0595383, P0595384, P0595385, P0595386, P0595387, P0595468, P0595469, P0595470, P0595471, P0595472, P0595473, P0595474, P0595475, P0595476, P0595477, P0595478, P0595479, P0595480, P0595481, P0595482, P0595483, P0595484, P0595485, P0595486, P0595487, P0595488, P0595489, P0595490, P0595491, P0595492, P0595493, P0595494, P0595495, P0595496, P0595497, P0595498, P0595499, P0595500, P0595840, P0595841, P0595842, P0595843, P0595844, P0595845, P0595846, P0595847, P0595848, P0595849, P0595850, P0595851, P0595852, P0595853, P0595854, P0595855, P0595856, P0595857, P0595858, P0595859, P0595860, P0595861, P0595862, P0595863, P0595864, P0595865, P0595866, P0595867, P0595868, P0595869, P0595870, P0595871, P0595872, P0596095, P0596096, P0596097, P0596098, P0596099, P0596100, P0596101, P0596102, P0596103, P0596104, P0596105, P0598683, P0598684, P0598685, P0598686, P0598687, P0598688, P0598689, P0598690, P0598691, P0598692, P0598693, P0598694, P0598695, P0598696, P0598697, P0598698, P0598699, P0598700, P0598701, P0598702, P0598703, P0598704, P0598705, P0598706, P0598707, P0598708, P0598709, P0598710, P0598711, P0598712, P0598713, P0598714, P0598715, P0598716, P0598717, P0598718, P0598719, P0598720, P0598721, P0598722, P0598724, P0598725, P0598726, P0598727, P0598728, P0598729, P0598730, P0598731, P0598732, P0598733, P0599603, P0599604, P0599605, P0599606, P0599607, P0599608, P0599609, P0599610, P0599611, P0599612, P0599613, P0599614, P0599615, P0599616, P0599617, P0599618, P0599619, P0599620, P0599621, P0599622, P0599623, P0599624, P0599625, P0599626, P0599627, P0599628, P0599629, P0599630, P0599631, P0599632, P0599633, P0599634, P0599635, P0599636, P0599637, P0599638, P0599639, P0599640, P0599641, P0599642, P0599643, P0599644, P0599645, P0599646, P0599647, P0599648, P0599649, P0599650, P0599651, P0599652, P0599653, P0599654, P0599655, P0599656, P0599657, P0599658, P0599659, P0599660, P0599661, P0599662, P0599663, P0599664, P0599665, P0599666, P0599667, P0599668, P0599669, P0599670, P0599671, P0599672, P0599673, P0599674, P0599675, P0599676, P0666913, P0666915, P0666918, P0666919, P0666921, P0666975, P0666976, P0666977, P0666978, P0666980, P0667291, P0667292, P0667293, P0667297, P0667298, P0667299, P0667301, P0667516, P0667524, P0739701, P0739702, P0739703, P0739704, P0748530, P0748531, P0748533, P0748538, P0748539, P0748540, P0748792, P0748793, P0748794, P0748795, P0748528, P0748529, P0657778, P0657779, P0657780, P0657781, P0657782, P0657783, P0657784, P0657785, P0657786, P0657787, P0657788, P0657887, P0657888, P0657889, P0657890, P0657891, P0657892, P0657893, P0657894, P0657895, P0657896, P0657897, P0658095, P0658096, P0658097, P0658098, P0658099, P0658100, P0658101, P0658102, P0658103, P0658104, P0658105, P0658288, P0658289, P0658290, P0658291, P0658292, P0658293, P0658294, P0658295, P0658296, P0658297, P0666911, P0666912, P0666914, P0666916, P0666917, P0666920, P0666973, P0666974, P0666979, P0666981, P0666982, P0666983, P0667294, P0667295, P0667296, P0667300, P0667517, P0667518, P0667519, P0667520, P0667521, P0667522, P0667523, P0667525, P0667636, P0667637, P0667638, P0667639, P0667640, P0667641, P0667642, P0667643, P0667644, P0667645, P0667646, P0667882, P0667883, P0667884, P0667885, P0667886, P0667887, P0668148, P0668149, P0668150, P0668151, P0668152, P0748532, P0748534, P0748535, P0748536, P0748537; b) UDI/DI 0505609734548, serial numbers: P0504661, P0510846, P0511315, P0511319, P0511323, P0511324, P0511325, P0511326, P0511327, P0511328, P0511329, P0511330, P0511331, P0511332, P0511333, P0511338, P0511345, P0511346, P0511949, P0514102, P0514103, P0514104, P0514108, P0514112, P0514113, P0514114, P0514115, P0514117, P0514118, P0515212, P0515213, P0515214, P0515216, P0515219, P0515223, P0515227, P0515228, P0515459, P0515460, P0515461, P0515462, P0515463, P0515464, P0515465, P0515466, P0515467, P0515468, P0515469, P0515493, P0515494, P0515495, P0515496, P0515497, P0515498, P0516243, P0516244, P0516245, P0516246, P0516247, P0516248, P0516249, P0516252, P0516253, P0516255, P0516257, P0517608, P0517613, P0517614, P0517617, P0517618, P0517619, P0517620, P0517623, P0517624, P0517625, P0517626, P0517627, P0517628, P0517629, P0517630, P0517631, P0517633, P0517635, P0517637, P0517639, P0517640, P0517642, P0517643, P0517644, P0517645, P0517646, P0517647, P0517648, P0517659, P0517660, P0517661, P0519063, P0519065, P0519066, P0519067, P0521574, P0521575, P0521576, P0521664, P0521665, P0521666, P0521667, P0521668, P0521669, P0526411, P0526412, P0526413, P0526414, P0526415, P0526416, P0526417, P0526418, P0526419, P0526420, P0526421, P0526422, P0526423, P0526424, P0537958, P0537959, P0537960, P0537961, P0537962, P0537963, P0537964, P0537965, P0537966, P0537967, P0537968, P0537969, P0537972, P0537973, P0537974, P0537976, P0537977, P0537978, P0537979, P0537980, P0654784, P0656430, P0656431, P0656432, P0656434, P0656437, P0672944, P0672970, P0672971, P0672972, P0672973, P0672974, P0672975, P0672976, P0673160, P0676796, P0676797, P0676798, P0676799, P0676800, P0676801, P0677092, P0677093, P0493385, P0493450, P0504658, P0504659, P0504660, P0504662, P0504663, P0504664, P0504665, P0504666, P0504667, P0504668, P0504669, P0504670, P0504671, P0504672, P0504673, P0504674, P0504675, P0504676, P0504677, P0504678, P0504679, P0504680, P0504681, P0504682, P0504683, P0504684, P0504685, P0504686, P0504687, P0504688, P0504689, P0510502, P0510503, P0510504, P0510505, P0510506, P0510507, P0510508, P0510509, P0510510, P0510511, P0510512, P0510513, P0510514, P0510515, P0510516, P0510517, P0510518, P0510519, P0510520, P0510521, P0510522, P0510523, P0510524, P0510525, P0510526, P0510527, P0510528, P0510529, P0510530, P0510531, P0510814, P0510815, P0510816, P0510817, P0510818, P0510819, P0510820, P0510821, P0510822, P0510823, P0510825, P0510826, P0510827, P0510828, P0510829, P0510830, P0510831, P0510832, P0510833, P0510834, P0510835, P0510836, P0510837, P0510838, P0510839, P0510840, P0510841, P0510842, P0510843, P0510844, P0510845, P0510847, P0510848, P0510849, P0510850, P0511308, P0511309, P0511310, P0511312, P0511313, P0511314, P0511316, P0511317, P0511318, P0511320, P0511321, P0511322, P0511334, P0511335, P0511336, P0511337, P0511339, P0511341, P0511342, P0511343, P0511344, P0511347, P0511936, P0511937, P0511938, P0511939, P0511940, P0511941, P0511942, P0511943, P0511944, P0511945, P0511946, P0511947, P0511948, P0511950, P0511951, P0511952, P0511953, P0511954, P0511955, P0512545, P0512546, P0514101, P0514105, P0514106, P0514107, P0514109, P0514110, P0514111, P0514116, P0515204, P0515205, P0515206, P0515207, P0515208, P0515209, P0515210, P0515211, P0515215, P0515217, P0515218, P0515220, P0515221, P0515222, P0515224, P0515225, P0515226, P0515492, P0516250, P0516251, P0516254, P0516256, P0517606, P0517607, P0517609, P0517610, P0517611, P0517612, P0517615, P0517616, P0517621, P0517622, P0517632, P0517634, P0517636, P0517638, P0517641, P0519064, P0537970, P0537971, P0537975, P0654777, P0654778, P0654779, P0654780, P0654781, P0654782, P0654783, P0654785, P0654786, P0656433, P0656435, P0656436, P0656865, P0656866, P0656867, P0656868, P0658673, P0658674, P0671818, P0671819, P0671820, P0671821, P0671822, P0671823, P0672942, P0672943, P0672945, P0672946, P0672947, P0672948, P0673158, P0673159, P0673161, P0676802, P0676803, P0676804, P0676805, P0677094, P0677095, P0677096, P0689004, P0690659, P0690660, P0690661, P0690662, P0697807, P0697808, P0697809, P0697810, P0701875, P0701876, P0701877, P0701878, P0702102, P0702103, P0702104, P0702105, P0702457, P0702458, P0702459, P0702460, P0702772, P0702773, P0702774, P0702775, P0493376, P0493377, P0493378, P0493379, P0493380, P0493381, P0493382, P0493383, P0493384, P0493386, P0493387, P0493388, P0493389, P0493390, P0493421, P0493422, P0493423, P0493424, P0493425, P0493426, P0493427, P0493428, P0493429, P0493430, P0493431, P0493432, P0493433, P0493434, P0493435, P0493436, P0493437, P0493438, P0493439, P0493440, P0493441, P0493442, P0493443, P0493444, P0493445, P0493446, P0493447, P0493448, P0493449, P0501237, P0501238, P0501239, P0501240, P0501241, P0501242, P0501243, P0501244, P0501245, P0501246, P0501247, P0501248, P0501249, P0501250, P0501251, P0501252, P0501253, P0501254, P0511340

Distribution pattern

US: TN, CA, NY, IL, NV, PA, SD