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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-2019-2019
Recall Event ID 83203
510(K)Number K052202  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product AXIOM Artis dTA, Model Number 7008605
Code Information Serial Numbers: 55163 55713 55304 55435 55567 55407 55412 55310 55470 55164 55187 55206 55091 55059 55204 55377 55307 55171 55368 55210 55133 55135 55477 55250 55318 55196 55230 55277 55423 55320 55387 55576 55438 55503 55046 55308 55139 55039 55270 55188 55314 55381 55550 55365 55574 55415 55109 55337 55322 55272 55157 55234 55548 55282 55575 55211 55410 55150 55079 55262 55259 55531 55388 55275 55276 55254 55569 55177 55269 55292 55041 55404 55425 55183 55441 55125 55369 55437 55136 55356 55191 55103 55400 55483 55083 55526 55088 55243 55056 55408 55715 55233 55416 55256 55074 55212 55153 55325 55312 55273 55213 55401 55170 55284 55469 55067 55048 55216 55241 55708 55202 55461 55154 55167 55342 55468 55219 55553 55217 55386 55396 55513 55279 55414 55347 55042 55294 55160 55286 55036 55362 55436 55375 55131 55062 55107 55411 55052 55096 55156 55289 55374 55705 55017 55223 55149 55141 55089 55305 55078 55227 55040 55200 55186 55184 55232 55358 55222 55313 55085 55090 55324 55045 55382 55350 55353 55405 55043 55439 55473 55070 55545 55434 55118 55455 55263 55274 55238 
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 178
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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