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U.S. Department of Health and Human Services

Class 1 Device Recall AVEA Ventilator

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  Class 1 Device Recall AVEA Ventilator see related information
Date Initiated by Firm September 05, 2013
Date Posting Updated September 27, 2013
Recall Status1 Terminated 3 on June 04, 2015
Recall Number Z-2273-2013
Recall Event ID 66219
510(K)Number K013642  K073069  K103211  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Product Name: AVEA¿ Ventilator.
All Models.
The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device.

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Code Information , AEV02056, AEV02060, AEV02062, AEV02063, AEV02064, AEV02066, AEV02070, AEV02071, AEV02072, AEV02076, AEV02078, AEV02079, AEV02080, AEV02082, AEV02087, AEV02088, AEV02089, AEV02091, AEV02092, AEV02094, AEV02095, AEV02099, AEV02102, AEV02106, AEV02108, AEV02110, AEV02114, AEV02117, AEV02118, AEV02119, AEV02120, AEV02122, AEV02123, AEV02124, AEV02125, AEV02130, AEV02136, AEV02138, AEV02141, AEV02142, AEV02144, AEV02145, AEV02148, AEV02151, AEV02154, AEV02158, AEV02160, AEV02161, AEV02162, AEV02164, AEV02165, AEV02166, AEV02168, AEV02169, AEV02170, AEV02171, AEV02172, AEV02174, AEV02175, AEV02177, AEV02178, AEV02179, AEV02180, AEV02181, AEV02182, AEV02183, AEV02184, AEV02185, AEV02186, AEV02187, AEV02188, AEV02192, AEV02197, AEV02202, AEV02204, AEV02205, AEV02206, AEV02207, AEV02208, AEV02209, AEV02211, AEV02213, AEV02214, AEV02221, AEV02222, AEV02225, AEV02226, AEV02228, AEV02229, AEV02230, AEV02233, AEV02234, AEV02236, AEV02237, AEV02239, AEV02243, AEV02244, AEV02248, AEV02249, AEV02252, AEV02253, AEV02254, AEV02255, AEV02258, AEV02259, AEV02260, AEV02261, AEV02262, AEV02264, AEV02265, AEV02266, AEV02268, AEV02269, AEV02272, AEV02274, AEV02275, AEV02276, AEV02277, AEV02279, AEV02283, AEV02285, AEV02287, AEV02288, AEV02292, AEV02293, AEV02296, AEV02298, AEV02299, AEV02300, AEV02301, AEV02303, AEV02306, AEV02309, AEV02310, AEV02311, AEV02313, AEV02318, AEV02320, AEV02321, AEV02323, AEV02325, AEV02326, AEV02327, AEV02328, AEV02329, AEV02331, AEV02332, AEV02333, AEV02334, AEV02337, AEV02339, AEV02340, AEV02341, AEV02342, AEV02347, AEV02350, AEV02351, AEV02355, AEV02356, AEV02357, AEV02358, AEV02359, AEV02360, AEV02361, AEV02362, AEV02363, AEV02364, AEV02365, AEV02366, AEV02367, AEV02369, AEV02370, AEV02371, AEV02372, AEV02373, AEV02375, AEV02376, AEV02378, AEV02380, AEV02381, AEV02383, AEV02384, AEV02385, AEV02386, AEV02387, AEV02390, AEV02391, AEV02394, AEV02395, AEV02406, AEV02407, AEV02409, AEV02411, AEV02412, AEV02414, AEV02415, AEV02417, AEV02419, AEV02420, AEV02421, AEV02422, AEV02423, AEV02424, AEV02425, AEV02426, AEV02427, AEV02428, AEV02430, AEV02432, AEV02435, AEV02440, AEV02441, AEV02442, AEV02443, AEV02445, AEV02446, AEV02447, AEV02448, AEV02449, AEV02450, AEV02455, AEV02456, AEV02461, AEV02466, AEV02471, AEV02472, AEV02473, AEV02474, AEV02475, AEV02476, AEV02477, AEV02478, AEV02480, AEV02482, AEV02484, AEV02488, AEV02491, AEV02495, AEV02497, AEV02499, AEV02500, AEV02504, AEV02505, AEV02506, AEV02507, AEV02513, AEV02515, AEV02518, AEV02521, AEV02523, AEV02524, AEV02525, AEV02526, AEV02537, AEV02544, AEV02545, AEV02547, AEV02548, AEV02549, AEV02551, AEV02552, AEV02554, AEV02556, AEV02557, AEV02561, AEV02562, AEV02565, AEV02566, AEV02571, AEV02574, AEV02575, AEV02576, AEV02577, AEV02580, AEV02581, AEV02585, AEV02586, AEV02587, AEV02588, AEV02589, AEV02590, AEV02591, AEV02594, AEV02601, AEV02602, AEV02608, AEV02612, AEV02613, AEV02614, AEV02617, AEV02620, AEV02627, AEV02629, AEV02631, AEV02635, AEV02636, AEV02643, AEV02644, AEV02648, AEV02653, AEV02654, AEV02656, AEV02657, AEV02662, AEV02665, AEV02666, AEV02667, AEV02670, AEV02674, AEV02675, AEV02679, AEV02681, AEV02682, AEV02684, AEV02685, AEV02691, AEV02693, AEV02694, AEV02695, AEV02696, AEV02697, AEV02699, AEV02700, AEV02704, AEV02706, AEV02707, AEV02708, AEV02709, AEV02710, AEV02712, AEV02713, AEV02717, AEV02718, AEV02719, AEV02720, AEV02721, AEV02723, AEV02725, AEV02726, AEV02727, AEV02728, AEV02729, AEV02730, AEV02736, AEV02738, AEV02739, AEV02743, AEV02744, AEV02745, AEV02746, AEV02747, AEV02750, AEV02752, AEV02753, AEV02755, AEV02757, AEV02760, AEV02761, AEV02763, AEV02766, AEV02768, AFV01001, AFV01002, AFV01003, AFV01005, AFV01006, AFV01008, AFV01010, AFV01013, AFV01017, AFV01022, AFV01028, AFV01029, AFV01030, AFV01034, AFV01037, AFV01040, AFV01042, AFV01043, AFV01047, AFV01048, AFV01053, AFV01054, AFV01055, AFV01057, AFV01062, AFV01064, AFV01065, AFV01068, AFV01072, AFV01075, AFV01076, AFV01078, AFV01079, AFV01081, AFV01090, AFV01092, AFV01097, AFV01105, AFV01114
Recalling Firm/
Carefusion 211 Inc dba Carefusion
22745 Savi Ranch Pkwy
Yorba Linda CA 92887-4668
Manufacturer Reason
for Recall
CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
FDA Determined
Cause 2
Component design/selection
Action CareFusion sent customer notification letters on September 05, 2013 via USPS mail return receipt carrier. The customer notification letter dated September 3, 2013 was titled "URGENT PRODUCT RECALL", and was addressed to Biomedical Engineering, Respiratory Care, and Risk Management. The customer notification letter informed customers of the product under recall with product name, description, and serial numbers enclosed as list unique to each customer. The customer notification letter also states the Problem and Affected Devices: Issue, Potential Risk, Actions to be Taken by CareFusion, Action to be Taken by the Customer, and Contact Information. Care Fusion has initiated a project to develop a new version of software that will resolve this issue. Once this software is available to download you will receive a notification letter. The customers were instructed to promptly return the enclosed Response Card to expedite the correction process and acknowledge receipt of this Notification and follow the listed instructions noted in the letter. For Recall Related and Support contact CareFusion Recall Support Center at 888.562.6018 or email: SupportCenter@carefusion .com Questions. For Product Technical Support Adverse Event Reporting contact Support/Customer Advocacy at 800.231.2466, 714.283.2228 or email to support.vent.us carefusion.com. from (6:30am -5:00pm POST). UPDATED: Firm issued press release of the recall on 09/30/2013.
Quantity in Commerce 19,546 units
Distribution Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
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 and Original Applicant = BIRD PRODUCTS CORP.
510(K)s with Product Code = CBK and Original Applicant = CAREFUSION
510(K)s with Product Code = CBK and Original Applicant = VIASYS RESPIRATORY CARE INC