AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Enforcement
- Recall Number
- Z-1136-2022
- Event ID
- 90058
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Umano Medical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 1, 2022
- Initiation Date
- April 11, 2022
- Classification Date
- May 26, 2022
- Termination Date
- January 17, 2024
- Address
- 230 Nilus-Leclerc Blvd, L'Islet, N/A, Canada
Description
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
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.
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
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.
355 units