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U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee/zeego

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  Class 2 Device Recall Artis zee/zeego see related information
Date Initiated by Firm February 14, 2020
Date Posted March 13, 2020
Recall Status1 Terminated 3 on April 20, 2021
Recall Number Z-1497-2020
Recall Event ID 85071
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis zee Biplane, Model No. 10094141;
Artis zee Ceiling, Model No. 10094137;
Artis zee Floor, Model No. 10094135;
Artis zeego, Model No. 10280959
Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Code Information Serial Numbers 154827 160851 148262 155168 154408 148299 137623 137714 125213 125238 125245 160869 147573 126202 161046 161041 154454 153834 147581 147857 147562 154532 147983 161218 160999 161032 161204 125001 161226 147604 153890 154721 154722 137193 138055 147760 147923 160449 160834 160852 138035 160944 137479 146245 160994 154567 160959 147803 125249 125241 154704 160913 148260 138087 160886 148335 154086 138112 161206 147841 155189 154727 147954 147918 160877 161008 148250 160997 147558 160864 160845 160448 138147 147955 147957 147958 160965 160800 154509 147724 138102 161236 125222 147953 137388 147553 131219 160823 147736 148215 148216 147974 154792 148298 137766 148025 160431 147972 137595 160916 137335 148282 160814 160872 146323 147992 147601 147659 147894 148010 147905 160915 125229 137421 131221 147249 153743 161021 147500 147969 148270 137119 147936 154683 160989 160501 161051 147681 147795 147845 160874 147652 161223 154653 154671 161007 154556 160862 160860 147541 147709 125223 161010 147587 154633 154020 147612 148022 160854 160429 137736 137752 138194 160149 154579 160878 148011 154560 155131 155191 125240 160856 153338 125208 125239 131223 154663 138005 160953 160903 138104 137656 138119 154592 131224 161005 160861 154684 160889 160813 161209 147668 160998 155195 137296 138015 160914 148352 147800 148254 148318 154471 148243 125210 154456 137229 147771 147944 161022 154546 161215 148278 148326 147988 147075 125201 125233 147839 161217 147655 147900 160940 148316 148273 160876 154678 148341 125214 148307 160885 155159 147287 161000 125227 125228 148207 148029 161050 124286 147717 154770 147952 148230 160825 148236 160850 155118 160942 148021 160873 161233 161234 125232 160840 147670 160956 161016 161017 147307 147718 148327 148375 154739 155150 160413 160414 160996 146705 160509 161004 160978 147301 147235 160551 148263 125244 160807 138051 161224 147937 147746 147528 147656 161235 148242 153744  ***Added 11/2/20*** 153640 146855 160493 154572 160967 147813 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Siemens Customer Service
800-888-7436
Manufacturer Reason
for Recall		 A software issue could potentially cause the stand and table movements to be blocked.
FDA Determined
Cause 2		 Software design
Action On February 14, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were informed of the software error which affects the listed systems. In case of software failure, planned procedures may have to be terminated and performed on an alternative x-ray system. Customers were instructed to do the following: Issue # 1: Potential issue with the Message "Stand battery charging: DO NOT POWER OFF" on Artis zeego systems Customer Action: Please check the system messages before power off/shutdown of the system. If possible, do not switch off the system while the message "Stand battery charging: DO NOT POWER OFF" is displayed and wait until the battery has been charged or replaced. Issue # 2: Potential issue of blocked stand movements on Artis zeego systems Issue # 3: Potential issue of blocked table movements on Artis zee/ Q/ Q.zen systems with Siemens Healthineers tables For Issues #2-3, customers may continue to use their systems, but in case the problem occurs, customers are instructed to follow standard emergency procedures in place in the event of system failures. Customers are encouraged to ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the software error via a software update. Siemens' service organization will contact customers to arrange a date to perform this corrective action. For an earlier appointment, please contact the firm's service organization at 1-800-888-7436.
Quantity in Commerce 1452 worldwide (638 US)
Distribution US Nationwide distribuiton.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solution USA, Inc.
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