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U.S. Department of Health and Human Services

Class 2 Device Recall Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics

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 Class 2 Recall
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics
see related information
Date Posted August 11, 2009
Recall Status1 Open
Recall Number Z-1813-2009
Recall Event ID 52439
Premarket Notification
510(K) Numbers
K001208  K034040  K041412  K051262  K072996  K981072 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456.
Code Information 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.
Recalling Firm/
Respironics California Inc
2271 Cosmos Ct
Carlsbad, California 92011-1517
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS CALIFORNIA, INC.
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.