Class 2 Device Recall IndiGo Intuitive Drive Assistance Module

• Date Initiated by Firm: August 29, 2023
• Date Posted: December 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0612-2024
• Recall Event ID: 93463
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: 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
• 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
• Recalling Firm/ Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.; Ul. Ks. Piotra Wawrzyniaka 2; Komorniki Poland
• Manufacturer Reason for Recall: Unintended movement of bed wheels
• FDA Determined Cause: Device Design
• Action: Arjo issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 08/29/2023 via US mail. The notice explained the problem with the device and provided instructions for risk mitigation until a permanent technical solution to the issue is available.
• Quantity in Commerce: 846 units
• Distribution: US: TN, CA, NY, IL, NV, PA, SD
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.