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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Aisys Anesthesia System

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 Class 2 Device Recall GE DatexOhmeda Aisys Anesthesia System see related information
Date Posted October 06, 2010
Recall Status1 Terminated on September 13, 2012
Recall Number Z-0008-2011
Recall Event ID 56599
510(K)Number K090233 
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Code Information 1302
ANAL01303
ANAL01304
ANAL01305
ANAL01306
ANAL01308
ANAL01325
ANAL01326
ANAL01327
ANAL01328
ANAL01329
ANAL01336
ANAL01337
ANAL01338
ANAL01339
ANAL01340
ANAL01341
ANAL01345
ANAL01346
ANAL01347
ANAL01348
ANAL01349
ANAL01350
ANAL01366
ANAL01367
ANAL01368
ANAL01369
ANAL01371
ANAL01372
ANAL01374
ANAL01375
ANAL01376
ANAL01377
ANAL01378
ANAL01379
ANAL01383
ANAL01384
ANAL01385
ANAL01386
ANAL01387
ANAL01388
ANAL01389
ANAL01390
ANAL01391
ANAL01394
ANAL01395
ANAL01397
ANAL01398
ANAL01399
ANAL01400
ANAL01401
ANAL01402
ANAL01403
ANAL01404
ANAL01405
ANAL01406
ANAL01407
ANAL01408
ANAL01409
ANAL01410
ANAL01415
ANAL01416
ANAL01418
ANAL01426
ANAL01427
ANAL01428
ANAL01429
ANAL01430
ANAL01431
ANAL01432
ANAL01433
ANAL01434
ANAL01435
ANAL01436
ANAL01437
ANAL01438
ANAL01439
ANAL01440
ANAL01441
ANAL01442
ANAL01443
ANAL01444
ANAL01445
ANAL01446
ANAL01447
ANAL01448
ANAL01449
ANAL01450
ANAL01451
ANAL01452
ANAL01453
ANAL01454
ANAL01455
ANAL01456
ANAL01457
ANAL01458
ANAL01461
ANAL01462
ANAL01463
ANAL01464
ANAL01465
ANAL01467
ANAL01468
ANAL01469
ANAL01470
ANAL01471
ANAL01472
ANAL01473
ANAL01474
ANAL01475
ANAL01476
ANAL01477
ANAL01478
ANAL01479
ANAL01480
ANAL01481
ANAL01482
ANAL01483
ANAL01486
ANAL01487
ANAL01488
ANAL01489
ANAL01490
ANAL01491
ANAL01492
ANAL01493
ANAL01494
ANAL01495
ANAL01496
ANAL01497
ANAL01498
ANAL01499
ANAL01500
ANAL01501
ANAL01502
ANAL01506
ANAL01508
ANAL01509
ANAL01510
ANAL01511
ANAL01512
ANAL01513
ANAL01514
ANAL01515
ANAL01516
ANAL01517
ANAL01518
ANAL01519
ANAL01520
ANAL01521
ANAL01522
ANAL01523
ANAL01524
ANAL01525
ANAL01526
ANAL01527
ANAL01528
ANAL01529
ANAL01530
ANAL01531
ANAL01532
ANAL01533
ANAL01534
ANAL01535
ANAL01536
ANAL01537
ANAL01538
ANAL01541
ANAL01542
ANAL01543
ANAL01551
ANAM00109
ANAM00110
ANAM00111
ANAM00112
ANAM00113
ANAM00114
ANAM00115
ANAM00116
ANAM00117
ANAM00118
ANAM00119
ANAM00120
ANAM00121
ANAM00122
ANAM00123
ANAM00126
ANAM00127
ANAM00128
ANAM00129
ANAM00130
ANAM00131
ANAM00132
ANAM00133
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ANAM00135
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ANAM00137
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ANAM00176-
ANAM00177
ANAM00187
ANAM00188
ANAM00189
ANAM00190
ANAM00191
ANAM00192
ANAM00193
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ANAM00195
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ANAM00210
ANAM00211
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ANAM00227
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ANAM00229
ANAM00230
ANAM00231
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ANAM00244
ANAM00245
ANAM00246
ANAM00247
ANAM00248
ANAM00249
ANAM00250
ANAM00251
ANAM00252
ANAM00253
ANAM00263
ANAM00264
ANAM00272
ANAM00273
ANAM00274
ANAM00275
ANAM00276
ANAM00277
ANAM00278
ANAM00292
ANAM00293
ANAM00294
ANAM00295
ANAM00296
ANAM00297
ANAM00298
ANAM00299
ANAM00300
ANAM00301
ANAM00302
ANAM00303
ANAM00304
ANAM00305
ANAM00306
ANAM00307
ANAM00308
ANAM00309
ANAM00310
ANAM00311
ANAM00312
ANAM00313
ANAM00314
ANAM00315
ANAM00316
ANAM00317
ANAM00318
ANAM00319
ANAM00320
ANAM00321
ANAM00322
ANAM00323
ANAM00324
ANAM00325
ANAM00326
ANAM00327
ANAM00328
ANAM00329
ANAM00330
ANAM00331
ANAM00332
ANAM00333
ANAM00334
ANAM00335
ANAM00336
ANAM00339
ANAM00340
ANAM00341
ANAM00342
ANAM00343
ANAM00344
ANAM00345
ANAM00346
ANAM00358
ANAM00359
ANAM00360
ANAM00361
ANAM00362
ANAM00363
ANAM00367
ANAM00368
ANAM00369
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ANAM00371
ANAM00372
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ANAM00374
ANAM00377
ANAM00378
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila
FDA Determined
Cause 2
Employee error
Action GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
Quantity in Commerce 3039
Distribution Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and 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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