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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-2024-2019
Recall Event ID 83203
510(K)Number K052202  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Artis dFA, Model Number 7555373
Code Information Serial Numbers: 50063 50059 50006 50064 50189 50044 50074 50101 51719 50062 50065 50087 50167 50039 50084 51706 51707 50048 50161 50093 50206 50057 50081 50133 50040 50016 50120 50191 51701 50027 51700 50139 50004 50010 50024 50142 50079 50132 50050 
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 39
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.