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

Recall details

Manufacturer

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Distributor

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

Lot

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, P0514

Risk classification

Class II

Area (FDA)

device

Country

Poland