Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive
Summary
The FDA issued a Class II for Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X a by ARJOHUNTLEIGH POLSKA Sp. z.o.o.. Reason: Unintended movement of bed wheels.
Details
Source
Device Recall
External ID
Z-0612-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 846 units
Reason for Recall
Unintended movement of bed wheels
Distribution
US: TN, CA, NY, IL, NV, PA, SD
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-29
Company
Komorniki
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 94 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ARJOHUNTLEIGH POLSKA Sp. z.o.o.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ARJOHUNTLEIGH POLSKA Sp. z.o.o. have FDA actions?
ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0612-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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