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Recall Observatory FDA recall evidence

Device product

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

Z-1136-2022

April 11, 2022

Class II

Product summary

Firm
Umano Medical, Inc.
Event
Event 90058
Status
Terminated
Classification
Class II
Quantity
355 units
Official record key
device-enforcement:Z-1136-2022

Official wording

Reason: There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

Code information: Model number: 200-0000; UDI: 00670482000487; Serial Numbers: 20004934, 20004933, 20004932, 20004931, 20004930, 20004929, 20004928, 20004927, 20004926, 20004925, 20004924, 20004923, 20004914, 20004886, 20004885, 20004884, 20004883, 20004882, 20004881, 20004880, 20004879, 20004878, 20004877, 20004876, 20004875, 20004874, 20004873, 20004872, 20004871, 20004870, 20004869, 20004868, 20004867, 20004866, 20004865, 20004864, 20004863, 20004862, 20004861, 20004860, 20004859, 20004858, 20004857, 20004856, 20004855, 20004854, 20004853, 20004852, 20004851, 20004850, 20004849, 20004848, 20004847, 20004846, 20004845, 20004844, 20004843, 20004842, 20004841, 20004840, 20004839, 20004812, 20004811, 20004810, 20004809, 20004808, 20004807, 20004806, 20004805, 20004804, 20004803, 20004802, 20004801, 20004800, 20004799, 20004798, 20004797, 20004796, 20004795, 20004794, 20004793, 20004792, 20004791, 20004790, 20004789, 20004788, 20004787, 20004786, 20004785, 20004784, 20004783, 20004782, 20004781, 20004712, 20004711, 20004710, 20004709, 20004777, 20004772, 20004721, 20004720, 20004719, 20004718, 20004717, 20004662, 20004661, 20004660, 20004659, 20004658, 20004657, 20004656, 20004655, 20004654, 20004653, 20004652, 20004651, 20004708, 20004707, 20004706, 20004705, 20004704, 20004703, 20004702, 20004701, 20004700, 20004699, 20004698, 20004697, 20004696, 20004695, 20004694, 20004693, 20004692, 20004691, 20004690, 20004689, 20004688, 20004687, 20004686, 20004685, 20004684, 20004683, 20004682, 20004681, 20004680, 20004679, 20004678, 20004677, 20004676, 20004675, 20004674, 20004673, 20004650, 20004649, 20004648, 20004647, 20004646, 20004645, 20004644, 20004643, 20004642, 20004641, 20004640, 20004639, 20004638, 20004637, 20004636, 20004627, 20004626, 20004625, 20004624, 20004623, 20004622, 20004621, 20004620, 20004619, 20004618, 20004617, 20004616, 20004615, 20004614, 20004613, 20004612, 20004611, 20004610, 20004609, 20004608, 20004607, 20004606, 20004605, 20004542, 20004541, 20004540, 20004539, 20004538, 20004537, 20004536, 20004535, 20004534, 20004533, 20004532, 20004531, 20004530, 20004529, 20004528, 20004527, 20004526, 20004525, 20004524, 20004523, 20004522, 20004521, 20004520, 20004519, 20004518, 20004517, 20004516, 20004515, 20004514, 20004513, 20004512, 20004511, 20004510, 20004509, 20004508, 20004507, 20004506, 20004505, 20004504, 20004503, 20004502, 20004501, 20004500, 20004499, 20004498, 20004497, 20004496, 20004495, 20004494, 20004493, 20004492, 20004491, 20004490, 20004489, 20004488, 20004487, 20004486, 20004485, 20004484, 20004483, 20004482, 20004481, 20004480, 20004479, 20004478, 20004477, 20004476, 20004475, 20004474, 20004473, 20004466, 20004465, 20004464, 20004463, 20004462, 20004461, 20004460, 20004459, 20004458, 20004457, 20004456, 20004455, 20004454, 20004453, 20004452, 20004451, 20004450, 20004449, 20004448, 20004447, 20004446, 20004445, 20004444, 20004443, 20004442, 20004441, 20004440, 20004439, 20004438, 20004437, 20004417, 20004416, 20004415, 20004414, 20004413, 20004412, 20004374, 20004373, 20004372, 20004371, 20004370, 20004369, 20004368, 20004367, 20004366, 20004247, 20004246, 20004380, 20004220, 20004219, 20004218, 20004210, 20004209, 20004208, 20004207, 20004206, 20004205, 20004204, 20004203, 20004202, 20004035, 20004034, 20004033, 20004032, 20004031, 20004030, 20004029, 20004028, 20004027, 20004022, 20004023, 20004024, 20004025, 20004026, 20004238, 20004239, 20004240, 20004241, 20004242, 20004243, 20004244, 20004248, 20004249, 20004250, 20004251, 20004252, 20004332, 20004333, 20004375, 20004376, 20004377, 20004378, 20004379, 20004835, 20004245

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.