Class 2 Device Recall AXIOM Artis Modular Angiographic System

• Date Initiated by Firm: June 12, 2019
• Create Date: July 22, 2019
• Recall Status: Terminated on September 18, 2020
• Recall Number: Z-2020-2019
• Recall Event ID: 83203
• 510(K)Number: K052202
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: AXIOM Artis dFC, Model Number 7412807
• Code Information: Serial Numbers: 37701 35374 35937 35456 35327 35368 35432 35690 35301 35451 35553 35427 35743 35750 35762 35778 35788 35764 35736 35350 35369 35601 35664 35730 35783 35376 35714 35547 35325 35314 35522 35635 35660 35333 35511 35536 35560 35329 35655 35810 35335 35353 35359 35410 35599 35556 35361 35283 35828 35380 35893 35351 35815 35306 35390 35525 35921 35727 35441 35465 37702 37713 35182 35974 35704 37705 35269 35339 35345 35516 37709 35486 35431 35512 35739 35834 35535 35305 35326 35471 35472 35334 35577 35202 35279 35860 35600 35309 35684 37710 35663 35346 35789 37715 35649 35615 35665 35768 35945 35312 35423 35241 35253 35610 35291 35629 35836 35603 35916 35707 35728 35698 35402 35571 35583 35666 35550 35821 35406 35626 35240 35668 37700 35540 35518 35179 35249 35504 35562 35566 35567 35501 35502 35623 35490 35545 35476 35709 35712 35744 35232 35452 35695 35678 35266 35793 35338 35784
• 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: 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: 148
• 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.