Z-1136-2022 Class II Terminated
FDA device recall Z-1136-2022 was initiated by Umano Medical, Inc. on April 11, 2022 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated January 17, 2024). Affected quantity: 355 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- April 11, 2022
- Termination Date
- January 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 355 units
Product Description
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Reason for Recall
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.
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.
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