AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Summary
The FDA issued a Class II for AC-powered adjustable medical beds with built-in electric DC actuators and contr by Umano Medical, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1135-2022
Action Date
2022-06-01
Status
Terminated
Category
device
Product Description
AC-powered adjustable medical beds with built-in electric DC actuators and controls.
Lot/Code Info: 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
Quantity Affected: 228 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-11
Company
L'Islet
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Umano Medical, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Umano Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Umano Medical, Inc. have FDA actions?
Umano Medical, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1135-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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