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U.S. Department of Health and Human Services

Class 2 Device Recall Artis Q

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  Class 2 Device Recall Artis Q see related information
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 and Original Applicant = Siemens Medical Solution USA, Inc.
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