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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Icono (VE2) System

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  Class 2 Device Recall ARTIS Icono (VE2) System see related information
Date Initiated by Firm September 18, 2020
Date Posted November 04, 2020
Recall Status1 Terminated 3 on July 23, 2021
Recall Number Z-0400-2021
Recall Event ID 86547
510(K)Number K193326  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: 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 ARTIS Icono biplane - model # 11327600 ARTIS Icono Floor - model # 11327700  Serial numbers: 1) 170023 2) 170025 3) 170026 4) 170027 5) 180014 6) 180015 7) 180018 8) 180019 9) 180021 10) 180029 11) 180034 12) 180035 13) 180037 14) 180040 15) 180041 16) 180043 17) 180046 18) 180047 19) 180048 20) 180049 21) 180053 22) 180054 23) 180055 24) 180057 25) 180060 26) 180062 27) 180065 28) 180066 29) 180067 30) 180068 31) 180070 ***Updated 11/6/2020*** 180072  
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.
FDA Determined
Cause 2		 Software design
Action A letter was sent to all affected customers on 09/18/2020 stating the following: Users are strongly recommended to not start releasing the x-ray for DSA (e.g. by pressing the pedal of the foot switch) until the system reaches the target position and has stopped moving. Siemens will correct this issue with a software patch via Update Instruction AX061/20/S. Siemens service organization will contact their affected customers to arrange a date to update the software. Customers can contact Siemens service organization for an earlier appointment by calling 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Customers are instructed to review the urgent medical device correction letter, and confirm acknowledgement of the information and instructions outlined in the letter. Customers are also instructed to promptly notify and instruct accordingly all of their staff at their respective organizations who need to be aware of this notice and comply with the recommendations therein. If customers have further distributed the device, they are instructed to identify those customers and notify them of this product recall immediately. Siemens also requests that customers inform Siemens who the new owners of the device are (when applicable).
Quantity in Commerce 100 distributed worldwide. 31 distributed nationwide in U.S.
Distribution 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 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 Solutions USA, Inc.
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