Events

Retiro De Equipo (Recall) de Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Respironics California Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    52439
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1813-2009
  • Fecha de inicio del evento
    2009-04-22
  • Fecha de publicación del evento
    2009-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83022
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    The recall was initiated because through routine product monitoring respironics discovered that under certain conditions, when operating on ac line power, a portion of the current from the external battery charger is erroneously diverted to the ventilator. when this occurs, the external battery charger may not transition correctly. prolonged operation in this condition results in overcharging and.
  • Acción
    Respironics California, Inc. issued an "Urgent - Medical Device Field Correction" notice dated April 22, 2009. Customers were informed of the affected device including corrective actions taken by the firm. A Respironics representative will contact customers to schedule service of the device. Further questions can be addressed by contacting Respironics US Customer Service at 1-800-345-6443.

Device

Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics
  • Modelo / Serial
    Serial Numbers: VS2700460, VS2700540, VS2700542, VS2700557, VS2700564, VS2700581, VS2700584, VS2700585, VS2700134, VS2700140, VS2700547, VS2700573, VS2700127, VS2700632, VS2700633, VS2700634, VS2700676, VS2700690, VS2700693, VS2700647, VS2700641, VS2700678, VS2700679, VS2700517, VS2500580, VS2700596, VS2700599, VS2700606, VS2700910, VS2701416, VS2700536, VS2700550, VS2700551, VS2700553, VS2700561, VS2700122, VS2700123, VS2700124, VS2700125, VS2700201, VS2700399, VS2700409, VS2700410, VS2700411, VS2700414, VS2700417, VS2700662, VS2700923, VS2700927, VS2700432, VS2700438, VS2700440, VS2700441, VS2700442, VS2700331, VS2700332, VS2700336, VS2700359, VS2700390, VS2700556, VS2700563, VS2700459, VS2700318, VS2700319, VS2700320, VS2700321, VS2700119, VS2700209, VS2700610, VS2700646A, VS2700691, VS2700630, VS2700360, VS2700412, VS2700200, VS2700463, VS2700464, VS2700466, VS2700467, VS2700468, VS2700469, VS2700470, VS2700473, VS2700474, VS2700476, VS2700477, VS2700478, VS2700479, VS2700480, VS2700481, VS2700431, VS2700433, VS2700434, VS2700435, VS2700436, VS2700437, VS2700439, VS2700471, VS2700472, VS2700475, VS2700355, VS2700392, VS2700102, VS2700138, VS2700141, VS2700206, VS2700207, VS2700356, VS2700358, VS2700368, VS2700383, VS2700384, VS2700385, VS2700386, VS2700387, VS2700388, VS2700391, VS2700613, VS2700619, VS2700621, VS2700622, VS2700623, VS2700346, VS2700348, VS2700349, VS2700350, VS2700351, VS2700352, VS2700353, VS2700354, VS2700361, VS2700362, VS2700363, VS2700365, VS2700366, VS2700367, VS2700370, VS2700375, VS2700377, VS2700380, VS2700381, VS2700382, VS2700508, VS2700512, VS2700526, VS2700528, VS2700529, VS2700322, VS2700328, VS2700329, VS2700330, VS2700403, VS2700405, VS2700407, VS2700408, VS2700506, VS2700515, VS2700516, VS2700393, VS2700394, VS2700395, VS2700413, VS2700415, VS2700418, VS2700419, VS2700424, VS2700426, VS2700427, VS2700428, VS2700430, VS2700698, VS2700920, VS2701403, VS2701407, VS2700333, VS2700334, VS2700335, VS2700337, VS2700338, VS2700339, VS2700340, VS2700342, VS2700343, VS2700443, VS2700444, VS2700445, VS2700448, VS2700450, VS2700451, VS2700452, VS2700454, VS2700672, VS2700692, VS2700906, VS2700908, VS2700915, VS2701401, VS2701405, VS2701404, VS2700208, VS2700211, VS2700213, VS2700232, VS2700236, VS2700396, VS2700397, VS2700398, VS2700615, VS2700629, VS2700530, VS2700611, VS2700453, VS2700525, VS2700531, VS2700105, VS2700142, VS2700143, VS2700909, VS2700913, VS2700914, VS2700132, VS2700456, VS2700644, VS2700685, VS2700696, VS2700701, VS2700325, VS2700327, VS2700715, VS2700916, VS2700369, VS2700371, VS2700372, VS2700373, VS2700374, VS2700376, VS2700378, VS2700379, VS2700583, VS2700635, VS2700640, VS2700643, VS2700646, VS2700713, VS2700937, VS2701417, VS2700677, VS2700549, VS2700558, VS2700578, VS2700543, VS2700577, VS2700121, VS2700567, VS2700919, VS2700237, VS2700300, VS2700502, VS2700505, VS2700513, VS2700518, VS2700519, VS2700520, VS2700680, VS2700700, VS2700710, VS2700712, VS2700911, VS2700912, VS2700918, VS2700921, VS2700922, VS2700924, VS2700625, VS2700628, VS2700651, VS2700652, VS2700608, VS2700447, VS2700210, VS2700212, VS2700216,, VS2700217, VS2700218, VS2700219, VS2700220, VS2700221, VS2700222, VS2700223, VS2700224, VS2700225, VS2700227, VS2700228, VS2700229, VS2700230, VS2700120, VS2700130, VS2700131, VS2700133, VS2700111, VS2700113, VS2700115, VS2700202, VS2700203, VS2700234, VS2700235, VS2700301, VS2700302, VS2700303, VS2700304, VS2700305, VS2700306, VS2700307, VS2700308, VS2700309, VS2700310, VS2700311, VS2700312, VS2700313, VS2700314, VS2700315, VS2700316, VS2700317, VS2700657, VS2700658, VS2700659, VS2700667, VS2700668, VS2700687, VS2700901, VS2700902, VS2700903, VS2700904, VS2700907, VS2700527, VS2700539, VS2700541, VS2700554, VS2700555, VS2700589, VS2700590, VS2700597, VS2700600, VS2700601, VS2700602, VS2700603, VS2700604, VS2700598, VS2700609, VS2700612, VS2700586, VS2700587, VS2700588, VS2700595, VS2700716,, VS2700455, VS2700503, VS2700504, VS2700509, VS2700511, VS2700534, VS2700535, VS2700545, VS2700552, VS2700559, VS2700571, VS2700572, VS2700620, VS2700669, VS2700682, VS2700707, VS2700905, VS2700917, VS2700457, VS2700501, VS2700507, VS2700510, VS2700521, VS2700522, VS2700523, VS2700666, VS2700705, VS2700706, VS2700708, VS2700649, VS2700650, VS2700661, VS2700703, VS2700704, VS2700686, VS2700544, VS2700565, VS2700566, VS2700568, VS2700592, VS2700593, VS2700594, VS2700458, VS2700537, VS2700548, VS2700576, VS2700607, VS2700591, VS2700617, VS2700538, VS2700546, VS2700574, VS2700579, VS2700688, VS2700695, VS2700697, VS2700699, VS2700673, VS2700532, VS2700533, VS2700560, VS2700562, VS2700569, VS2700570, VS2700582, VS2700616, VS2700618, VS2700935, VS2700943, VS2700925, VS2700926, VS2700928, VS2700929, VS2700930, VS2700931, VS2700932, VS2700933, VS2700934, VS2700936, VS2700446, VS2700449, VS2700461, VS2700462, VS2700465, VS2701402, VS2701406, VS2700341, VS2700357, VS2700345, VS2700347, VS2700344, VS2700655, VS2700656, VS2700660, VS2700663, VS2700664, VS2700665, VS2700670, VS2700674, VS2700675,, VS2700683, VS2701653, VS2701655, VS2700204, VS2700205, VS2700214, VS2700215, VS2700684, VS2700694, VS2700118, VS2700714, VS2700231, VS2700233, VS2700401, VS2700402, VS2700404, VS2700406, VS2700420, VS2700421, VS2700422, VS2700423, VS2700702, VS2700938, VS2700109, VS2700126, VS2700129, VS2700135, VS2700136, VS2700137, VS2700139, VS2700654, VS2700671, VS2700719, VS2700108, VS2700389, VS2700614, VS2700626, VS2700627, VS2700128, VS2700689, VS2700717, VS2700718, VS2700709, VS2700711, VS2700939, VS2700940, VS2700941, VS2700942, VS2700636, VS2700637, VS2700638, VS2700639 and VS2700631.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.
  • Descripción del producto
    Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Dirección del fabricante
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA