Date Initiated by Firm |
April 13, 2022 |
Date Posted |
June 06, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1243-2022 |
Recall Event ID |
90175 |
510(K)Number |
K150493
|
Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
Product |
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
|
Code Information |
UDI-DI: 04056869010137
Material Serial
6623974 40108
6623974 41202
6623974 41017
6623974 42308
6623974 6101
6623974 41021
6623974 6110
6623974 6622
6623974 6727
6634633 3021
6634633 2272
6634633 2563
6634633 2589
6634633 20380
6634633 3112
6634633 2291
6634633 3405
6634633 3406
6634633 3440
6634633 3407
6634633 3408
6634633 3437
6634633 22267
6634633 21334
6634633 3417
6634633 3564
6634633 2060
6634633 2154
6634633 2155
6634633 2201
6634633 3037
6634633 3038
6634633 3041
6634633 3166
6634633 3224
6634633 3226
6634633 3352
6634633 3534
6634633 3536
6634633 20102
6634633 20134
6634633 20137
6634633 20149
6634633 20314
6634633 22688
6634633 2520
6634633 2521
6634633 2506
6634633 2709
6634633 2739
6634633 3072
6634633 21212
6634633 2552
6634633 2744
6634633 3060
6634633 20062
6634633 20574
6634633 2442
6634633 2444
6634633 2500
6634633 2501
6634633 2025
6634633 2276
6634633 2408
6634633 3622
6634633 3650
6634633 3653
6634633 3670
6634633 3671
6634633 3676
6634633 2578
6634633 22427
6634633 20448
6634633 21034
6634633 21035
6634633 21043
6634633 22336
6634633 21037
6634633 21051
6634633 21052
6634633 21095
6634633 21100
6634633 21102
6634633 21438
6634633 22022
6634633 2515
6634633 3390
6634633 2282
6634633 2331
6634633 2332
6634633 20321
6634633 20045
6634633 20047
6634633 3333
6634633 20598
6634633 2203
6634633 3091
6634633 3097
6634633 3059
6634633 3472
6634633 22671
6634633 2434
6634633 20525
6634633 20556
6634633 20557
6634633 2022
6634633 2032
6634633 2629
6634633 20392
6634633 22406
6634633 20594
6634633 20637
6634633 22611
6634633 20162
6634633 22612
6634633 3319
6634633 21399
6634633 22037
6634633 21384
6634633 21395
6634633 21452
6634633 3475
6634633 21332
6634633 22345
6634633 22357
6634633 22366
6634633 2403
6634633 20407
6634633 20033
6634633 22509
6634633 3075
6634633 2225
6634633 20430
6634633 22282
6634633 2113
6634633 2186
6634633 2187
6634633 3049
6634633 3050
6634633 22461
6634633 22462
6634633 22415
6634633 22312
6634633 22663
6634633 22667
6634633 3069
6634633 3128
6634633 3129
6634633 20026
6634633 3316
6634633 22512
6634633 22438
6634633 2608
6634633 3529
6634633 3641
6634633 20538
6634633 21109
6634633 21383
6634633 22341
6634633 2350
6634633 2352
6634633 21297
6634633 22000
6634633 20133
6634633 2205
6634633 2224
6634633 2227
6634633 2229
6634633 21056
6634633 2293
6634633 22628
6634633 22651
6634633 22652
6634633 22670
6634633 20585
6634633 20023
6634633 20399
6634633 20385
6634633 2428
6634633 20561
6634633 22480
6634633 20319
6634633 20618
6634633 22523
6634633 22526
6634633 22528
6634633 22619
6634633 22623
6634633 22627
6634633 22646
6634633 22669
6634633 22681
6634633 22682
6634633 22720
6634633 20139
6634633 22051
6634633 3660
6634633 3101
6634658 8067
6634658 8068
6648153 16001
6648153 16000
6648153 10661
6648153 10883
6648153 16005
6648153 16004
6648153 10700
6648153 10666
6648153 10886
6648153 16100
6648153 10887
6648153 10704
6648153 10723
6648161 11053
6648161 18103
6648161 18104
6648161 11657
6648161 11882
6648161 11251
6648161 18101
6648161 11661
6648161 18105
6648161 18000
6648161 18001
6648161 18002
6648161 11855
6648161 11856
10140973 13240
10140973 13419
10140973 13450
10140973 13215
10140973 13218
10140973 13423
10140973 13272
10140973 13483
10140973 13479
10140973 13243
10140973 13461
10140973 13466
10140973 13467
10140973 13402
10140973 13212
10764561 61297
10764561 60130
10764561 61084
10764561 61108
10764561 60410
10764561 60138
10764561 60412
10764561 60110
10764561 61072
10764561 60147
10764561 60370
10764561 60372
10764561 60125
10764561 60128
10764561 60060
10764561 60116
10764561 60120
10764561 60127
10764561 60129
10764561 60134
10764561 60143
10764561 61083
10764561 61031
10764561 61330
10764561 60079
10764561 61061
10764561 61230
10764561 61232
10764561 61086
10764561 61207
10764561 60369
10764561 60308
10764561 60312
10764561 60040
10764561 61313
10764561 61128
10764561 61133
10764561 61138
10764561 60023
10764561 60024
10764561 60025
10764561 61225
10764561 61310
10764561 61143
10764561 60052
10764561 60468
10764561 60322
10764561 61201
10764561 61224
10764561 60474
10764561 60022
10764561 60089
10764561 61144
10764561 61246
10764561 61088
10764561 60166
10764561 60087
10764561 61241
10764561 60325
10764561 61299
10764561 61302
10764561 61305
10764561 61315
10764561 61309
10764561 61317
10764561 61318
10764561 61239
10764561 61320
10764561 61186
10764561 60062
10764561 61325
10764561 60436
10764561 60444
10764561 60453
10764561 60483
10764561 61064
10764561 61183
10764561 61009
10764561 61169
10764561 60058
10764561 60095
10764561 60311
10764561 61129
10764561 60395
10764561 61281
10764561 61014
10764561 60323
10764561 61008
10764561 61292
10764561 60020
10764561 61136
10764561 61141
10764561 61142
10764561 60359
10764561 61103
10764561 60171
10764561 61121
10764561 61219
10764561 61345
10764561 61198
10764561 60427
10764561 61124
10764561 61403
10764561 61048
10764561 61251
10764561 61253
10764561 61256
10764561 61266
10764561 60473
10764561 61002
10764561 61116
10764561 61394
10764561 61344
10764561 60111
10764561 60123
10764561 61081
10764561 61234
10764561 60347
10764561 60348
10764561 61151
10764561 60355
10764561 60167
10764561 61030
10764561 61089
10764561 60065
10764561 60480
10764561 60154
10764561 61071
10764561 60146
10765502 15134
10765502 15010
10765502 15105
10765502 15111
10765502 15122
10765502 15011
10765502 15121
10765502 15130
10765502 15129
10765502 15143
10765502 15144
10765502 15146
10765502 15001
10765502 15821
10765502 15116
10765502 15108
10765502 15117
10765502 15120
10765502 15112
10765502 15115
10765502 15124
10765502 15125
10765502 15132
10765502 15133
10765502 15013
10765502 15106
10765502 15150
10910620 14326
10910620 14049
10910620 14050
10910620 14058
10910620 14046
10910620 14112
10910620 14113
10910620 14118
10910620 14109
10910620 14014
10910620 14015
10910620 14117
10910620 14119
10910620 14108
10910620 14041
10910620 14308
10910620 14000
10910620 14012
10910620 14127
10910620 14103
10910620 14059
10910620 14304
10910620 14311
10910620 14106
10910620 14325
10910620 14017
10910620 14104
10910620 14004
10910620 14002
10910620 14313
10910620 14121
10910620 14301
10910620 14309
10910620 14305
10910620 14322
10910620 14105
10910620 14315
10910620 14007
10910620 14055
10910620 14110
10910620 14111
10910620 14320
10910620 14302
10910620 14009
10910620 14057
***Update 8/31/22 - the following units have been removed from the scope of this correction ***
6634633 20314
6634633 20102
6634633 20149
6634633 2506
6634633 2709
6634633 2739
6634633 3072
6634633 21212
6634633 3622
6634633 3670
6634633 3676
6648161 18103
6648161 18104
10764561 61230
10764561 61232
6634633 2434
10764561 61088
10765502 15130
6634633 20594
6634633 20637
6634633 22611
6634633 3319
10765502 15146
10765502 15001
6634633 20033
6634633 22509
10140973 13272
6648161 18105
10764561 61234
6648153 16005
6634633 2203
10764561 60359
6634633 20133
6648153 16001
6648161 11053
10764561 61136
6648161 18101
6634633 21395
10765502 15013
10765502 15106
10910620 14117
10910620 14119
6634633 2442
6634633 2444
6634633 2500
6634633 2501
10764561 61031
6634633 3069
***Updated 11/9/22 - The following systems have been added to this correction***
6634633 3136
10140973 13253
***Updated 1/13/23 - Added the following system***
Material Serial
6623974 42320
|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
Meredith Adams 610-219-4834
|
Manufacturer Reason for Recall |
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
|
FDA Determined Cause 2 |
Software Design Change |
Action |
On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action.
Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436. |
Quantity in Commerce |
443 |
Distribution |
Domestic distribution nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = DQK and Original Applicant = Siemens Medical Solutions, Inc.
|