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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 Posted September 27, 2013
Recall Status1 Terminated 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
ADV06223
ADV06224
ADV06226
ADV06227
ADV06230
ADV06231
ADV06232
ADV06234
ADV06235
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ADV06321
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ADV06405
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ADV06420
AEV01002
AEV01009
AEV01011
AEV01020
AEV01032
AEV01036
AEV01037
AEV01038
AEV01039
AEV01040
AEV01046
AEV01049
AEV01052
AEV01057
AEV01500
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AEV01508
AEV01509
AEV01512
AEV01515
AEV01518
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AEV01521
AEV01527
AEV01528
AEV01530
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AEV01561
AEV01562
AEV01563
AEV01564
AEV01566
AEV01568
AEV01569
AEV01570
AEV01572
AEV01574
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AEV01576
AEV01577
AEV01578
AEV01579
AEV01580
AEV01583
AEV01584
AEV01586
AEV01587
AEV01589
AEV01590
AEV01591
AEV01592
AEV01593
AEV01594
AEV01595
AEV01597
AEV01600
AEV01602
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AEV01604
AEV01605
AEV01606
AEV01607
AEV01608
AEV01609
AEV01610
AEV01611
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AEV01613
AEV01614
AEV01615
AEV01616
AEV01617
AEV01618
AEV01619
AEV01620
AEV01621
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AEV01624
AEV01625
AEV01626
AEV01627
AEV01628
AEV01629
AEV01631
AEV01632
AEV01633
AEV01638
AEV01639
AEV01640
AEV01641
AEV01642
AEV01645
AEV01646
AEV01647
AEV01648
AEV01651
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AEV01654
AEV01656
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AEV01660
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AEV01664
AEV01665
AEV01670
AEV01674
AEV01675
AEV01677
AEV01679
AEV01682
AEV01683
AEV01684
AEV01685
AEV01687
AEV01688
AEV01689
AEV01690
AEV01691
AEV01692
AEV01694
AEV01695
AEV01696
AEV01697
AEV01701
AEV01703
AEV01704
AEV01708
AEV01709
AEV01710
AEV01711
AEV01712
AEV01713
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AEV01716
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AEV01719
AEV01720
AEV01721
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AEV01727
AEV01728
AEV01729
AEV01730
AEV01731
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AEV01741
AEV01742
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AEV01749
AEV01753
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AEV01757
AEV01761
AEV01762
AEV01763
AEV01764
AEV01765
AEV01766
AEV01768
AEV01770
AEV01771
AEV01772
AEV01773
AEV01774
AEV01775
AEV01776
AEV01777
AEV01779
AEV01780
AEV01781
AEV01782
AEV01783
AEV01785
AEV01788
AEV01791
AEV01792
AEV01793
AEV01796
AEV01797
AEV01798
AEV01799
AEV01801
AEV01802
AEV01806
AEV01807
AEV01809
AEV01810
AEV01812
AEV01813
AEV01814
AEV01815
AEV01816
AEV01817
AEV01818
AEV01821
AEV01822
AEV01825
AEV01829
AEV01831
AEV01834
AEV01835
AEV01837
AEV01840
AEV01841
AEV01843
AEV01844
AEV01845
AEV01846
AEV01847
AEV01851
AEV01854
AEV01855
AEV01859
AEV01865
AEV01866
AEV01870
AEV01876
AEV01883
AEV01884
AEV01886
AEV01887
AEV01888
AEV01894
AEV01896
AEV01897
AEV01903
AEV01906
AEV01908
AEV01909
AEV01911
AEV01912
AEV01914
AEV01919
AEV01921
AEV01922
AEV01923
AEV01926
AEV01928
AEV01929
AEV01930
AEV01931
AEV01932
AEV01933
AEV01934
AEV01936
AEV01937
AEV01939
AEV01942
AEV01943
AEV01944
AEV01945
AEV01946
AEV01947
AEV01948
AEV01951
AEV01952
AEV01953
AEV01955
AEV01958
AEV01961
AEV01962
AEV01964
AEV01968
AEV01969
AEV01972
AEV01974
AEV01978
AEV01979
AEV01981
AEV01984
AEV01986
AEV01987
AEV01993
AEV01995
Recalling Firm/
Manufacturer
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 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 = 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
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