510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-1813-2009

Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number...

Respironics, Inc. / initiated 2009-04-22 / Terminated / root cause: design
FDA source (opens on fda.gov)

Respironics California Inc began a recall of Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1813-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Respironics, Inc.
Product
Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
Product code
CBK Ventilator, Continuous, Facility Use
Reason for recall
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
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
508
Distribution
Worldwide Distribution: United States, Hong Kong, India, Mexico, South Africa and Vietnam.
Product codes and lots
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.