Device product
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Z-1135-2022
Product summary
- Event
- Event 90058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 228 units
- Official record key
device-enforcement:Z-1135-2022
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: 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
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
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.