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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis Modular Angiographic System

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  Class 2 Device Recall AXIOM Artis Modular Angiographic System see related information
Date Initiated by Firm June 12, 2019
Create Date July 22, 2019
Recall Status1 Terminated 3 on September 18, 2020
Recall Number Z-2022-2019
Recall Event ID 83203
510(K)Number K052202  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Artis dBA, Model Number 7555357
Code Information Serial Numbers: 53181 53023 53167 53104 53067 53093 53162 53706 53058 53098 53253 53016 53188 53209 53223 53700 53017 53114 53063 53219 53033 53142 53116 53002 53086 53195 53165 53076 53064 53124 53176 53078 53111 53227 53202 53133 53140 53047 53710 53190 53180 53128 53185 53170 53187 53019 53141 53084 53074 53225 53215 53189 53056 53166 53149 53020 53096 53009 53147 53070 53049 53261 53122 53065 53031 53085 53026 53222 53090 53075 53256 53045 53057 53103 53182 53012 53022 53175 53194 53102 53109 53260 53043 53160 53117 
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		 A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
FDA Determined
Cause 2		 Component design/selection
Action Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. Our service organization will contact you 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. Following the correction, the cause is eliminated and any recurrence of this potential fault is prevented.
Quantity in Commerce 85
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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