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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee/zeego &; Artis Q/Q.zen

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  Class 2 Device Recall Artis zee/zeego &; Artis Q/Q.zen see related information
Date Initiated by Firm December 16, 2022
Date Posted January 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-1040-2023
Recall Event ID 91418
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product System Material #
Artis zee floor 10094135
Artis zee ceiling 10094137
Artis zee multi-purpose 10094139
Artis zee biplane 10094141
Artis zeego 10280959
Artis Q floor 10848280
Artis Q ceiling 10848281
Artis Q biplane 10848282
Artis Q.zeego 10848283
Artis Q.zen floor 10848353
Artis Q.zen ceiling 10848354
Artis Q.zen biplane 10848355



Fluoroscopic X-Ray System
Code Information Artis zee floor UDI-DI 4056869010045 Serial Numbers 138481 124714 138390 138497 124709 124395 138102 138071 124383 124706 137617 137607 139133 137752 137736 138325 138358 139120 124378 124713 139127 138397 138367 124703 138070 124388 124708 139012 139023 124724 138340 138051 Artis zee ceiling UDI-DI 4056869010052 Serial numbers 150011 150062 148498 150060 150002 147983 150017 148486 148487 148488 125716 148260 148288 147954 125267 125269 147956 147958 147957 147955 148001 148277 125700 147974 150040 125705 147969 148270 150036 150005 148019 147120 147119 148361 150023 148479 147114 125257 125119 148431 148474 150009 150015 148029 147952 148484 148466 148489 125715 150003 150046 150047 125254 148240 148239 Artis zee multi-purpose UDI-DI 4056869010076 Serial numbers 159088 159190 158650 158652 158742 159124 130241 159157 159030 159085 159117 130714 159034 158225 159156 159038 159181 159032 159046 158183 159175 158272 159054 159099 158519 159177 158495 159015 159127 159058 159028 158744 159147 159037 158206 159132 159026 130708 158180 159041 159176 159042 159152 158638 130720 159158 158597 159168 158211 158458 159180 159047 159025 159024 159192 159021 130715 158468 158678 159182 159148 158786 159113 158658 159102 159100 159080 159079 158510 158227 159049 159065 157702 158599 159010 Artis zee biplane UDI-DI 4056869010069 Serial numbers 154827 155265 131707 155151 156011 154794 156014 154799 154814 155131 155310 155266 131247 155286 153999 131252 Artis zeego UDI-DI 4056869010083 Serial numbers 161226 161008 161021 161051 161209 161022 161233 161224 Artis Q floor UDI-DI 4056869009971 Serial numbers 103218 104049 104007 104016 104005 104061 104027 132508 132510 104051 103030 103258 104012 103384 104029 104020 103008 104025 103222 132507 103230 104047 104062 104013 132502 132509 132500 103048 132000 103245 103348 Artis Q ceiling UDI-DI 4056869009988 Serial numbers 110199 110088 110059 110223 110103 133503 110035 110166 110046 110005 109812 109727 110058 110156 110176 110180 110147 109931 110181 110056 110062 110158 109074 109388 109352 110221 133201 133000 109789 110234 110207 110195 110209 109523 109645 109166 110067 110161 109817 110227 110184 110169 110119 110144 110167 110095 109134 109133 109084 110051 109833 110001 110020 110192 109688 110007 110131 109432 109434 110093 110128 110219 109384 109378 109598 109893 110096 109653 109621 109748 110236 109451 133504 109102 109431 109383 109785 109794 110198 109015 110069 110106 110139 109662 110185 110075 110214 109803 109627 109772 110179 110235 110063 110042 110061 110064 110048 110043 110032 110047 110102 110039 110040 110023 110014 110159 110110 110230 110065 109848 110052 109057 110018 110224 109103 109165 110228 110191 110136 110201 110072 109741 109129 110145 109034 109181 109678 110081 110036 110182 110233 110232 110054 109795 109179 109661 109699 109155 110109 109424 110053 110107 109072 109071 110044 110031 109300 110175 110193 110187 110016 110196 109041 110077 110037 109497 109039 110079 110211 110210 110099 110113 110217 109560 110027 110134 110049 110117 110066 110024 109088 110017 110186 110025 109096 109159 109358 110231 110154 110183 110208 109364 110100 110129 110190 110188 110083 110091 109301 110006 110115 109302 109369 110055 109854 109844 109350 109069 109648 109158 110026 110022 109028 109027 109120 110000 109705 109677 110152 133501 109739 110177 110057 109774 110132 110104 109044 133508 110174 110041 109917 133509 110149 110216 Artis Q biplane UDI-DI 4056869009995 Serial numbers 121314 122049 122025 121336 122012 122055 121612 122040 122021 122028 121623 122060 122037 122005 121374 121014 121112 121209 121621 121133 121163 122039 121018 121154 121354 122046 121340 121205 122034 121324 121078 122042 134003 121563 122050 121635 121355 121010 121395 121551 121633 121190 134504 121039 121416 121417 122001 121012 121049 134502 134500 122033 121120 121122 121121 122010 121148 122048 122007 121004 122016 121175 121057 121056 121419 121466 122013 121525 121319 121058 121085 121377 121375 121393 121339 121310 121199 122017 134506 121533 122024 122027 121591 121046 121313 122014 Artis Q.zeego UDI-DI 4056869010007 Serial numbers 117316 117108 117125 117020 117123 117117 117304 117310 117303 117113 117014 Artis Q.zen floor UDI-DI 4056869010014 Serial numbers 105110 105500 105007 105503 105018 143500 105135 105501 105142 105017 105123 105121 105122 105112 Artis Q.zen ceiling UDI-DI 4056869010021 111502 111517 111523 111503 111005 111002 111510 111527 111507 111512 111508 111521 111133 111529 111524 111504 111526 111513 111010 111175 111528 111506 111525 111500 111501 111169 111505 111166 111107 111514 Artis Q.zen biplane UDI-DI 4056869010038 Serial numbers 123043 123031 123008 123255 123252 123032 123209 123208 123508 123514 123505 123213 123513 123251 123022 123510 123509 123502 123201 123023 123501 123216 123249 123037 123511 123512 123244
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		 In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
FDA Determined
Cause 2		 Software design
Action On December 16, 2022, the firm initiated the recall to its affected customers via Urgent Medical Device Correction letters. Customers were instructed to do the following: Observe if the system suffers an abrupt shutdown. This can be caused e.g., by usage of the Emergency SHUTDOWN button, manually switching off via End session / Shutdown System command in the main menu, or by a long press on the power-on push button on the system console. In the event of an abrupt shutdown, restart immediately to verify system state and call service if necessary. The firm will provide a software patch to affected systems. Siemens's service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 609 US; 1627 worldwide
Distribution Worldwide - US Nationwide distribution.
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 = OWB and Original Applicant = Siemens Medical Solution USA, Inc.
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