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

• Date Initiated by Firm: April 22, 2009
• Date Posted: August 11, 2009
• Recall Status: Terminated on July 13, 2012
• Recall Number: Z-1813-2009
• Recall Event ID: 52439
• 510(K)Number: K001208 K034040 K041412 K051262 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.
• FEI Number: 2518422
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 760-918-7300
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = CBK; 510(K)s with Product Code = CBK