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Class 2 Device Recall Freedom1000 |
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Date Initiated by Firm |
April 11, 2022 |
Create Date |
May 26, 2022 |
Recall Status1 |
Terminated 3 on January 17, 2024 |
Recall Number |
Z-1135-2022 |
Recall Event ID |
90058 |
Product Classification |
Bed, ac-powered adjustable hospital - Product Code FNL
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Product |
AC-powered adjustable medical beds with built-in electric DC actuators and controls. |
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
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Recalling Firm/ Manufacturer |
Umano Medical, Inc. 230 Nilus-Leclerc Blvd L'Islet Canada
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Manufacturer 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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted. |
Quantity in Commerce |
228 units |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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