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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-2027-2019
Recall Event ID 83203
510(K)Number K052202  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Artis dBC, Model Number 7728392
Code Information Serial Numbers: 44125 44151 44101 44246 44185 44262 44263 44199 44105 44084 44080 44072 44243 44198 44171 44275 44215 44255 44081 44242 44265 44189 44289 44145 44060 44144 44184 44286 44223 44068 44193 44244 44201 44251 44229 44304 44152 44136 44254 44277 44279 44268 44206 44278 44259 44260 44168 44267 44110 44218 44165 44271 44135 
Recalling Firm/
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
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 53
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.