FDAFDA · Alimentos y medicamentos·N.º oficial Z-1351-2020
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330
Publicado el 4 de marzo de 2020 · Inicio del retiro: 22 de enero de 2020
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
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- St Jude Medical, Cardiac Rhythm Management Division
- Distribuidor
- U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK. O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria, Australia
- Lote
- Serial #: 1138400, 1138406, 1138391, 1138393, 1138403, 1138366, 1138387, 1138396, 1138386, 1138399, 1138374, 1138362, 1138368, 1138397, 1138401, 1138372, 1138375, 1138382, 1138380, 1138405, 1138377, 1138371, 1138390, 1138398, 1138367, 1138395, 1138389, 1138379, 1138370, 1138388, 1138364, 1138373, 1138385, 1138394, 1138381, 1138404, 1138392, 1138384, 1138376, 1138369, 1138365, 1138465, 1138620, 1138573, 1138590, 1138407, 1138408, 1138409, 1138411, 1138412, 1138413, 1138415, 1138416, 1138417, 1138419, 1138421, 1138422, 1138423, 1138424, 1138429, 1138431, 1138435, 1138436, 1138437, 1138441, 1138442, 1138467, 1138468, 1138469, 1138513, 1138612, 1138613, 1138615, 1138616, 1138617, 1138624, 1138626, 1138420, 1138587, 1138628, 1138510, 1138619, 1138428, 1138432, 1138433, 1138445, 1138446, 1138447, 1138449, 1138451, 1138455, 1138466, 1138470, 1138471, 1138474, 1138479, 1138488, 1138502, 1138507, 1138523, 1138538, 1138544, 1138548, 1138556, 1138575, 1138576, 1138577, 1138580, 1138597, 1138599, 1138608, 1138495, 1138503, 1138547, 1138563, 1138565, 1138581, 1138585, 1138543, 1138461, 1138501, 1138505, 1138508, 1138545, 1138546, 1138553, 1138557, 1138566, 1138567, 1138583, 1138588, 1138486, 1138489, 1138490, 1138491, 1138496, 1138497, 1138500, 1138542, 1138549, 1138550, 1138551, 1138555, 1138559, 1138560, 1138561, 1138564, 1138570, 1138579, 1138582, 1138586, 1138611, 1138618, 1138472, 1138482, 1138595, 1138589, 1138614, 1138434, 1138440, 1138443, 1138448, 1138450, 1138452, 1138453, 1138456, 1138457, 1138458, 1138459, 1138460, 1138462, 1138463, 1138464, 1138473, 1138476, 1138478, 1138480, 1138481, 1138514, 1138515, 1138516, 1138518, 1138519, 1138520, 1138521, 1138522, 1138524, 1138525, 1138526, 1138527, 1138528, 1138529, 1138530, 1138531, 1138532, 1138533, 1138534, 1138536, 1138537, 1138539, 1138540, 1138594, 1138596, 1138600, 1138601, 1138602, 1138603, 1138604, 1138605, 1138606, 1138607, 1138609, 1138622, 1138623, 1138631, 1138632, 1138633, 1138634, 1138635, 1138636, 1138487, 1138494, 1138552, 1138554, 1138610, 1138621, 1138493, 1138499, 1138504, 1138569, 1138627, 1138484, 1138571, 1138425, 1138426, 1138438, 1138439, 1138444, 1138498, 1138492, 1138509, 1138541, 1138558, 1138562, 1138568, 1138584, 1138578, 1138511, 1138512, 1138572, 1138591, 1138592, 1138593, 1138625, 1138485, 1138574, 1138430, 1138598, 1138402, 1138363, 1138454, 1138410, 1138383, 1138378, 1138517, 1138535, 1138418, 1138506, 1138414, 1138427, 1138475, 1138477, 1138483, 1138630
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.