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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
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/
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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