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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0565-2013

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

Publicado el 26 de diciembre de 2012 · Inicio del retiro: 2 de noviembre de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Del Mar Reynolds Medical, Ltd.
Distribuidor
Worldwide Distribution--USA (nationwide) including states of North Carolina and Oklahoma and the countries of Algeria, Argentina, Bahrain, Bangladesh, Bolivia, Chile, China, Columbia, Dominican Republic, Ecuador, Egypt, Finland, Ghana, Great Britian, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Pakistan, Palestine, Paraguay, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates , Uruguay, Venezuela, and Vietnam.
Lote
Serial numbers for three workstations in the US: focu-101917; focu-101909; and focu-101881. Serial numbers for BleaseFocus workstations in other countries: FOCO-100076, FOCO-100077, FOCO-100078, FOCO-100079, FOCO-100080, FOCO-100081, FOCU-000353, FOCU-000354, FOCU-000355, FOCU-000356, FOCU-000357, FOCU-000364, FOCU-000365, FOCU-000405, FOCU-000406, FOCU-000407, FOCU-000408, FOCU-000409, FOCU-000410, FOCU-000411, FOCU-000412, FOCU-000413, FOCU-000414, FOCU-000415, FOCU-000416, FOCU-000417, FOCU-000418, FOCU-000419, FOCU-000420, FOCU-000421, FOCU-000422, FOCU-000423, FOCU-000424, FOCU-000425, focu-000454, FOCU-000455, FOCU-000456, FOCU-000457, FOCU-000458, FOCU-000459, FOCU-000460, FOCU-000461, FOCU-000462, FOCU-000463, focu-000464, FOCU-000465, FOCU-000466, FOCU-000467, FOCU-000468, FOCU-000469, FOCU-000470, FOCU-000471, FOCU-000472, FOCU-000473, FOCU-000474, FOCU-000475, FOCU-000476, FOCU-000477, FOCU-000478, FOCU-000479, FOCU-000480, FOCU-000481, FOCU-000482, FOCU-000483, FOCU-000484, FOCU-000485, FOCU-000486, FOCU-000487, FOCU-000488, FOCU-000489, FOCU-000490, FOCU-000491, FOCU-000492, FOCU-000493, FOCU-000494, FOCU-000495, FOCU-000496, FOCU-000497, FOCU-000498, FOCU-000499, FOCU-000500, FOCU-000501, FOCU-000502, FOCU-000503, FOCU-000504, FOCU-000505, FOCU-000506, FOCU-000507, FOCU-000508, FOCU-000509, FOCU-000510, FOCU-000511, FOCU-000512, FOCU-000513, FOCU-000514, FOCU-000515, FOCU-000516, FOCU-000517, FOCU-000518, FOCU-000519, FOCU-000520, FOCU-000521, FOCU-000522, FOCU-000523, FOCU-000524, FOCU-000525, FOCU-000526, FOCU-000527, FOCU-000528, FOCU-000529, FOCU-000530, FOCU-000531, FOCU-000532, FOCU-000533, FOCU-000534, FOCU-000535, FOCU-000536, FOCU-000537, FOCU-000538, FOCU-000539, FOCU-000540, FOCU-000541, FOCU-000542, FOCU-000543, FOCU-000544, FOCU-000545, FOCU-000546, FOCU-000547, FOCU-000548, FOCU-000549, FOCU-000550, FOCU-000551, FOCU-000552, FOCU-000553, FOCU-000554, FOCU-000555, FOCU-000556, FOCU-000557, FOCU-000558, FOCU-000562, FOCU-000565, FOCU-000566, FOCU-000567, FOCU-000568, FOCU-000569, FOCU-000570, FOCU-000571, FOCU-000572, FOCU-000573, FOCU-000574, FOCU-000575, FOCU-000576, FOCU-000577, FOCU-000578, focu-000579, focu-000580, FOCU-000581, FOCU-000582, FOCU-000583, FOCU-000584, FOCU-000585, FOCU-000586, FOCU-000587, FOCU-000588, FOCU-000589, FOCU-000590, FOCU-000591, FOCU-000592, FOCU-000593, FOCU-000594, FOCU-000595, FOCU-000596, FOCU-000597, FOCU-000598, FOCU-000599, FOCU-000600, FOCU-000601, FOCU-000602, FOCU-000603, FOCU-000604, FOCU-000605, FOCU-000606, FOCU-000607, FOCU-000608, FOCU-000609, FOCU-000610, FOCU-000611, FOCU-000612, FOCU-000613, FOCU-000614, FOCU-000615, FOCU-000616, FOCU-000617, FOCU-000618, FOCU-000619, FOCU-000620, FOCU-000621, FOCU-000622, FOCU-000623, focu-000624, FOCU-000625, focu-000626, FOCU-000627, FOCU-000628, FOCU-000629, FOCU-000630, FOCU-000631, FOCU-000632, FOCU-000633, FOCU-000634, FOCU-000635, FOCU-000636, FOCU-000637, FOCU-000638, FOCU-000639, FOCU-000640, FOCU-000641, FOCU-000642, FOCU-000643, FOCU-000644, focu-000645, focu-000646, FOCU-000647, focu-000648, focu-000649, FOCU-000650, FOCU-000651, FOCU-000652, FOCU-000653, FOCU-000654, FOCU-000655, FOCU-000656, FOCU-000657, FOCU-000658, FOCU-000659, FOCU-000660, FOCU-000661, FOCU-000662, FOCU-000663, FOCU-000664, FOCU-000665, FOCU-000666, FOCU-000667, FOCU-000668, FOCU-000669, FOCU-000670, FOCU-000671, FOCU-000672, FOCU-000673, FOCU-000674, FOCU-000675, FOCU-000676, FOCU-000677, FOCU-000678, FOCU-000679, FOCU-000680, focu-000681, focu-000682, focu-000683, focu-000684, focu-000685, focu-000686, focu-000687, focu-000688, focu-000689, focu-000690, FOCU-000691, FOCU-000692, FOCU-000693, FOCU-000694, FOCU-000695, FOCU-000696, focu-000697, FOCU-000698, FOCU-000699, FOCU-000700, FOCU-000701, FOCU-000702, FOCU-000703, FOCU-000704, FOCU-000705, FOCU-000706, FOCU-000707, FOCU-000708, FOCU-000709, FOCU-000710, FOCU-000711, FOCU-000712, FOCU-000713, FOCU-000714, FOCU-000715, FOCU-000716, FOCU-000717, FOCU-000718, FOCU-000719, F
Clasificación de riesgo
Class II
Área (FDA)
device
País
United Kingdom

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