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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-2021-2019
Recall Event ID 83203
510(K)Number K052202  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Artis dTC, Model Number 7413078
Code Information Serial Numbers: 46022 46023 46154 46107 46263 46091 46203 46100 46025 46034 46042 46063 46036 46245 46062 46198 46169 46272 46117 46051 46137 46157 46215 46216 46219 46220 46221 46108 46040 46124 46126 46225 46226 46120 46152 46223 46130 46241 46213 46128 46205 46231 46098 46133 46271 46060 46085 46201 46182 46122 46065 46143 46144 46186 46097 46111 46067 46138 46269 46054 46125 46194 46190 46168 46180 46044 46127 46204 46112 46115 46118 46150 46164 46103 46113 46270 46178 46047 46106 46156 46202 46167 46163 46045 46158 46210 46179 46256 46192 46176 46170 46171 46174 46101 46139 46061 46035 46239 
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 98
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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