FDAFDA · Food and drugs·Recall number Z-1135-2022
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Published June 1, 2022 · Recall initiated: April 11, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Umano Medical, Inc.
- Distributor
- 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.
- Lot
- Model number: FM1000; UDI: 00670482000487; Serial Numbers: FM100000704, FM100000703, FM100000716, FM100000715, FM100000714, FM100000713, FM100000712, FM100000711, FM100000710, FM100000709, FM100000708, FM100000707, FM100000706, FM100000705, FM100000702, FM100000701, FM100000700, FM100000699, FM100000698, FM100000697, FM100000696, FM100000695, FM100000694, FM100000693, FM100000692, FM100000691, FM100000690, FM100000689, FM100000688, FM100000657, FM100000656, FM100000655, FM100000654, FM100000653, FM100000687, FM100000686, FM100000685, FM100000684, FM100000683, FM100000682, FM100000681, FM100000680, FM100000679, FM100000678, FM100000677, FM100000676, FM100000675, FM100000674, FM100000673, FM100000672, FM100000671, FM100000670, FM100000669, FM100000668, FM100000667, FM100000666, FM100000665, FM100000664, FM100000663, FM100000662, FM100000661, FM100000660, FM100000659, FM100000658, FM100000652, FM100000651, FM100000650, FM100000649, FM100000648, FM100000647, FM100000646, FM100000645, FM100000644, FM100000643, FM100000642, FM100000641, FM100000640, FM100000639, FM100000638, FM100000637, FM100000636, FM100000635, FM100000634, FM100000633, FM100000632, FM100000631, FM100000630, FM100000629, FM100000628, FM100000627, FM100000626, FM100000625, FM100000624, FM100000623, FM100000622, FM100000621, FM100000620, FM100000619, FM100000618, FM100000617, FM100000616, FM100000615, FM100000614, FM100000613, FM100000612, FM100000611, FM100000610, FM100000609, FM100000608, FM100000607, FM100000606, FM100000605, FM100000604, FM100000603, FM100000602, FM100000601, FM100000600, FM100000599, FM100000598, FM100000597, FM100000596, FM100000595, FM100000594, FM100000593, FM100000592, FM100000591, FM100000590, FM100000589, FM100000588, FM100000587, FM100000586, FM100000585, FM100000584, FM100000583, FM100000582, FM100000581, FM100000580, FM100000579, FM100000578, FM100000577, FM100000576, FM100000575, FM100000574, FM100000573, FM100000572, FM100000567, FM100000566, FM100000565, FM100000571, FM100000570, FM100000569, FM100000568, FM100000564, FM100000563, FM100000562, FM100000561, FM100000560, FM100000559, FM100000558, FM100000557, FM100000556, FM100000555, FM100000554, FM100000553, FM100000552, FM100000551, FM100000550, FM100000549, FM100000548, FM100000547, FM100000546, FM100000545, FM100000544, FM100000543, FM100000542, FM100000541, FM100000540, FM100000539, FM100000538, FM100000537, FM100000536, FM100000535, FM100000534, FM100000533, FM100000532, FM100000531, FM100000530, FM100000529, FM100000528, FM100000527, FM100000526, FM100000525, FM100000524, FM100000523, FM100000522, FM100000521, FM100000520, FM100000519, FM100000518, FM100000517, FM100000516, FM100000515, FM100000514, FM100000513, FM100000512, FM100000511, FM100000510, FM100000509, FM100000508, FM100000507, FM100000491, FM100000490, FM100000489, FM100000488, FM100000487, FM100000486, FM100000485, FM100000484, FM100000483, FM100000482, FM100000458, FM100000457, FM100000456, FM100000455, FM100000454, FM100000453, FM100000452, FM100000451
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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