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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 AL01197
ANAL01198
ANAL01199
ANAL01200
ANAL01201
ANAL01202
ANAL01203
ANAL01205
ANAL01206
ANAL01214
ANAL01215
ANAL01216
ANAL01217
ANAL01218
ANAL01219
ANAL01220
ANAL01221
ANAL01222
ANAL01223
ANAL01224
ANAL01225
ANAL01226
ANAL01227
ANAL01228
ANAL01229
ANAL01230
ANAL01231
ANAL01232
ANAL01233
ANAL01234
ANAL01235
ANAL01236
ANAL01237
ANAL01238
ANAL01239
ANAL01240
ANAL01241
ANAL01242
ANAL01243
ANAL01244
ANAL01245
ANAL01246
ANAL01254
ANAL01255
ANAL01258
ANAL01279
ANAL01287
ANAL01300
ANAL01302
ANAL01303
ANAL01304
ANAL01305
ANAL01306
ANAL01308
ANAL01325
ANAL01326
ANAL01327
ANAL01328
ANAL01329
ANAL01336
ANAL01337
ANAL01338
ANAL01339
ANAL01340
ANAL01341
ANAL01345
ANAL01346
ANAL01347
ANAL01348
ANAL01349
ANAL01350
ANAL01383
ANAL01384
ANAL01385
ANAL01386
ANAL01387
ANAL01388
ANAL01389
ANAL01394
ANAL01395
ANAL01397
ANAL01398
ANAL01399
ANAL01400
ANAL01401
ANAL01402
ANAL01403
ANAL01404
ANAL01405
ANAL01406
ANAL01407
ANAL01408
ANAL01409
ANAL01410
ANAL01415
ANAL01416
ANAL01418
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
ANAL01507
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
ANAL01551
ANAM00109
ANAM00110
ANAM00111
ANAM00112
ANAM00113
ANAM00114
ANAM00115
ANAM00116
ANAM00117
ANAM00118
ANAM00119
ANAM00120
ANAM00121
ANAM00122
ANAM00123
ANAM00126
ANAM00158
ANAM00159
ANAM00160
ANAM00161
ANAM00162
ANAM00163
ANAM00164
ANAM00165
ANAM00166
ANAM00167
ANAM00168
ANAM00169
ANAM00170
ANAM00171
ANAM00172
ANAM00173
ANAM00174
ANAM00175
ANAM00176
ANAM00177
ANAM00187
ANAM00188
ANAM00189
ANAM00190
ANAM00191
ANAM00192
ANAM00193
ANAM00194
ANAM00195
ANAM00196
ANAM00197
ANAM00198
ANAM00199
ANAM00200
ANAM00201
ANAM00206
ANAM00207
ANAM00208
ANAM00227
ANAM00228
ANAM00229
ANAM00230
ANAM00231
ANAM00232
ANAM00233
ANAM00234
ANAM00235
ANAM00236
ANAM00237
ANAM00238
ANAM00239
ANAM00240
ANAM00241
ANAM00242
ANAM00243
ANAM00244
ANAM00245
ANAM00246
ANAM00247
ANAM00248
ANAM00249
ANAM00250
ANAM00251
ANAM00252
ANAM00253
ANAM00263
ANAM00264
ANAM00272
ANAM00273
ANAM00274
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
ANAM00367
ANAM00368
ANAM00369
ANAM00370
ANAM00371
ANAM00372
ANAM00373
ANAM00374
ANAM00377
ANAM00378
ANAM00379
ANAM00380
ANAM00381
ANAM00382
ANAM00383
ANAM00384
ANAM00385
ANAM00386
ANAM00387
ANAM00388
ANAM00389
ANAM00390
ANAM00391
ANAM00392
ANAM00393
ANAM00394
ANAM00395
ANAM00396
ANAM00397
ANAM00398
ANAM00399
ANAM00400
ANAM00401
ANAM00402
ANAM00403
ANAM00404
ANAM00405
ANAM00406
ANAM00407
ANAM00408
ANAM00409
ANAM00410
ANAM00421
ANAM00423
ANAM00424
ANAM00425
ANAM00426
ANAM00427
ANAM00439
ANAM00440
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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