Date Initiated by Firm | August 10, 2022 |
Date Posted | August 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1645-2022 |
Recall Event ID |
90771 |
510(K)Number | K181407 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Artis Q floor- Model No. 10848280
Artis Q ceiling- Model No. 10848281
Artis Q biplane- Model No. 10848282
Artis Q zeego- Model No. 10848283
Artis Q.zen floor- Model No. 10848353
Artis Q.zen ceiling- Model No. 10848354
Artis Q.zen biplane- Model No. 10848355 |
Code Information |
Artis Q floor- Model No. 10848280
UDI-DI: 4056869009971
Serial Numbers
103221
103217
104049
103409
103232
104005
104027
132508
132510
103359
104051
103220
104029
103365
104025
103286
103222
132507
104047
132502
132509
132500
103241
103212
103254
103255
***Updated 9/23/22***
103035
***Updated 1/9/23***
103444
103050
Artis Q ceiling- Model No. 10848281
UDI-DI: 4056869009988
Serial Numbers
109552
110088
110199
110059
110103
133503
110166
109123
110005
109344
109628
110058
110156
110176
110180
110147
110181
110056
110158
109074
109479
109197
109421
109792
109738
109405
110195
109437
109645
109166
110067
110161
110184
110169
110119
109747
110144
109760
110095
110167
110192
110131
109169
110093
109769
133202
109202
110109
110128
109378
109384
110096
109621
133504
110198
109015
110069
110106
110139
109211
109726
110185
110075
109674
109627
109780
110179
110063
110047
110102
109656
109309
110023
110110
110159
110065
110052
109057
109915
110191
109604
110136
110201
109457
110072
109034
109129
110145
109181
109884
109643
109678
110081
109330
109058
110182
109380
109222
109435
110054
109188
109518
109458
109155
109379
109538
109752
109659
110053
110107
109591
109630
109393
110196
110175
109920
110193
110187
110077
109164
110079
109362
109762
110099
110113
109717
110134
109564
109813
110049
110117
110066
109088
110186
109397
109685
109096
109159
110154
110183
109715
109364
110100
110129
110188
110190
109463
110083
110091
109048
109742
109301
109020
109036
109818
110115
109664
109163
109105
110055
109854
109069
109010
109756
110152
133501
109156
109157
109307
110177
110057
109391
110132
110104
110174
110149
***Updated 9/23/22***
110223
110227
110224
110228
109225
109358
133508
133509
***Updated 1/9/23***
109417
109066
110048
110014
110233
Artis Q biplane- Model No. 10848282
UDI-DI: 4056869009995
Serial Numbers
122049
121665
121564
122025
121627
121185
121336
122012
121471
121467
121612
122022
121094
122040
121006
122021
122028
121013
121501
121208
121459
121011
122037
121054
121422
121209
121325
121357
121369
121133
121200
121163
121364
122039
121154
121418
121442
122046
121205
122034
121137
121012
121049
122042
121332
121183
121455
121019
121381
121352
122050
121434
121165
121625
121415
121355
121010
121210
121573
121215
121323
121370
121556
121384
121487
122017
121395
121405
121513
121342
121301
121081
121649
121190
121424
134505
121629
121529
121138
121039
121521
121600
121193
121554
121179
121216
121566
121417
121151
121188
121168
121106
134502
134500
122033
121411
121120
121121
121541
122010
122048
121436
121359
121622
121141
121648
121535
122016
121175
121439
121419
121008
121152
121155
121160
121449
122013
121576
121379
121085
121361
121206
121431
121544
121211
121187
121197
121375
121377
121505
121601
121506
121616
121594
121510
121533
122024
122027
121041
121502
122014
***Updated 1/9/23***
121015
121309
121633
122032
121653
121393
134506
Artis Q zeego- Model No. 10848283
UDI-DI: 4056869010007
Serial Numbers
117316
117330
117006
117034
117026
117123
117111
117024
117309
117113
117322
117040
117041
***Updated 9/23/22***
117136
Artis Q.zen floor- Model No. 10848353
UDI-DI: 4056869010014
Serial Numbers
105007
105503
105018
105119
105125
Artis Q.zen ceiling- Model No. 10848354
UDI-DI: 4056869010021
Serial Numbers
111162
111163
111137
111502
111523
111174
111510
111527
111155
111140
111507
111124
111512
111521
111133
111110
111101
111524
111526
111149
111109
111151
111130
111517
111513
111017
111120
111127
111157
111142
111525
111107
111514
111128
***Updated 1/9/23***
111529
111530
111528
***Updated 1/13/23***
111535
Artis Q.zen biplane- Model No. 10848355
UDI-DI: 4056869010038
Serial Numbers
123245
123026
123031
123050
123008
123255
123247
123254
123221
123508
123505
123510
123205
123509
123230
123239
123010
***Updated 1/9/23***
123225
123513
|
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 a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown. |
FDA Determined Cause 2 | Device Design |
Action | On August 10, 2022, the firm notified customers via "URGENT: MEDICAL DEVICE CORRECTION" Letter. Customers were advised that if the error occurs, the user should try to recover normal operation by a shutdown and restart of the system.
Siemens will correct the error with a hardware modification via Update Instruction AX028/22/S and AX039/22/S. Siemens' service organization will contact customers shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
If you have any further questions, call 610-219-4834 or email: meredith.adams@siemens-healthineers.com.
|
Quantity in Commerce | 1,389 (590 US; 799 OUS) (Total) |
Distribution | Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan;
Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.
|
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 = JAK
|