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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys

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 Class 2 Device Recall Aisys see related information
Date Posted June 23, 2009
Recall Status1 Terminated on December 10, 2011
Recall Number Z-1425-2009
Recall Event ID 51202
510(K)Number K073707 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
Code Information
ANAM00441
ANAM00442
ANAM00443
ANAM00444
ANAM00445
ANAM00446
ANAM00447
ANAM00448
ANAM00449
ANAM00450
ANAM00451
ANAM00452
ANAM00453
ANAM00454
ANAM00455
ANAM00456
ANAM00457
ANAM00458
ANAM00463
ANAM00464
ANAM00465
ANAM00466
ANAM00467
ANAM00468
ANAM00469
ANAM00470
ANAM00471
ANAM00472
ANAM00473
ANAM00484
ANAM00485
ANAM00486
ANAM00487
ANAM00488
ANAM00489
ANAM00490
ANAM00491
ANAM00492
ANAM00493
ANAM00494
ANAM00495
ANAM00496
ANAM00497
ANAM00498
ANAM00499
ANAM00500
ANAM00501
ANAM00502
ANAL00796
ANAL00797
ANAL00798
ANAL00799
ANAL00800
ANAK00107
ANAK00108
ANAK00109
ANAK00243
ANAK00244
ANAK00245
ANAK00246
ANAK00422
ANAK00647
ANAK00648
ANAK00649
ANAK00666
ANAK00667
ANAK00668
ANAL00238
ANAL01351
ANAL01352
ANAL01353
ANAL01354
ANAL01355
ANAL01356
ANAL01357
ANAL01358
ANAM00219
ANAM00220
ANAM00221
ANAM00222
ANAM00223
ANAM00224
ANAK00146
ANAK00734
ANAK00735
ANAK00736
ANAL00307
ANAL00432
ANAK00575
ANAJ00124
ANAK00234
ANAK00470
ANAL00395
ANAL00440
ANAL00441
ANAL00748
ANAL01411
ANAJ00104
ANAK00118
ANAK00119
ANAK00120
ANAK00207
ANAK00441
ANAK00442
ANAK00443
ANAK00444
ANAK00445
ANAK00446
ANAK00447
ANAK00448
ANAK00449
ANAK00450
ANAK00451
ANAK00452
ANAK00453
ANAK00454
ANAK00455
ANAK00720
ANAL00295
ANAL00296
ANAL00510
ANAL00511
ANAL00512
ANAL00513
ANAL00514
ANAL00515
ANAL00516
ANAL00517
ANAL00518
ANAL00519
ANAL00520
ANAL00521
ANAL00522
ANAL00523
ANAL00524
ANAL00525
ANAL00526
ANAL00527
ANAL00528
ANAL00529
ANAL00530
ANAL00559
ANAL01366
ANAL01367
ANAL01368
ANAL01369
ANAL01371
ANAL01372
ANAL01374
ANAL01375
ANAL01376
ANAL01377
ANAL01378
ANAL01379
ANAM00127
ANAM00128
ANAM00129
ANAM00130
ANAM00131
ANAM00132
ANAM00133
ANAM00134
ANAM00135
ANAM00136
ANAM00137
ANAM00138
ANAM00139
ANAM00140
ANAM00141
ANAM00142
ANAM00143
ANAM00144
ANAM00145
ANAM00146
ANAM00339
ANAM00340
ANAM00341
ANAM00342
ANAM00343
ANAM00344
ANAM00345
ANAM00346
ANAM00358
ANAM00359
ANAM00360
ANAM00361
ANAM00362
ANAM00363
ANAK00281
ANAK00282
ANAK00531
ANAK00532
ANAK00533
ANAK00534
ANAK00535
ANAK00536
ANAK00537
ANAK00538
ANAK00539
ANAK00540
ANAK00541
ANAK00542
ANAK00543
ANAK00544
ANAK00545
ANAK00546
ANAK00547
ANAK00548
ANAK00549
ANAK00550
ANAK00551
ANAK00552
ANAK00553
ANAK00554
ANAK00555
ANAK00556
ANAK00557
ANAK00558
ANAK00559
ANAK00560
ANAK00561
ANAK00562
ANAK00563
ANAK00564
ANAK00565
ANAK00566
ANAK00567
ANAK00568
ANAK00569
ANAK00570
ANAK00571
ANAK00572
ANAK00573
ANAK00742
ANAK00743
ANAL00306
ANAL00767
ANAL01307
ANAK00466
ANAK00467
ANAK00468
ANAK00469
ANAK00507
ANAK00508
ANAL00278
ANAL00489
ANAL00602
ANAL00603
ANAL00604
ANAL00605
ANAL00606
ANAL00607
ANAL00608
ANAL00609
ANAL00610
ANAL00611
ANAL00612
ANAL00613
ANAL00614
ANAL00625
ANAL00629
ANAL00630
ANAL00768
ANAL00858
ANAL00859
ANAL00864
ANAL00925
ANAL00926
ANAL00927
ANAL00928
ANAL00929
ANAL00930
ANAM00265
ANAM00266
ANAM00267
ANAM00268
ANAM00269
ANAM00270
ANAM00271
ANAM00282
ANAM00283
ANAM00284
ANAM00285
ANAM00286
ANAM00287
ANAM00288
ANAM00289
ANAM00290
ANAM00291
ANAK00854
ANAK00152
ANAK00153
ANAK00154
ANAK00155
ANAK00357
ANAK00645
ANAK00646
ANAL00488
ANAL00655
ANAL00656
ANAL00657
ANAL00658
ANAL00659
ANAL00660
ANAL00715
ANAL00716
ANAK00341
ANAK00729
ANAK00730
ANAK00731
ANAK00732
ANAK00733
ANAK00283
ANAK00498
ANAK00499
ANAK00500
ANAK00893
ANAK00894
ANAK00895
ANAK00896
ANAK00897
ANAK00898
ANAK00899
ANAK00900
ANAK00901
ANAK00902
ANAL00907
ANAL00908
ANAL00909
ANAL00910
ANAL00911
ANAL00912
ANAL00913
ANAL00914
ANAL00915
ANAL00916
ANAL01382
ANAM00428
ANAM00429
ANAM00430
ANAM00431
ANAM00432
ANAM00433
ANAM00434
ANAM00435
ANAM00436
ANAM00437
ANAK00335
ANAK00336
ANAK00654
ANAK00655
ANAK00656
ANAL01256
ANAL01257
ANAK00402
ANAK00403
ANAK00404
ANAK00405
ANAK00406
ANAK00407
ANAK00408
ANAK00590
ANAM00150
ANAM0
Recalling Firm/
Manufacturer
GE Healthcare
9900 Innovation Drive
Mail Stop: RP2138
Wauwatosa WI 53226
Manufacturer Reason
for Recall
Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h
FDA Determined
Cause 2
Component design/selection
Action GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Quantity in Commerce 3082
Distribution Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.
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 = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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