Class 2 Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM; Artis Zee/Zeego & Artis Q/Q.Zen

• Date Initiated by Firm: March 30, 2021
• Create Date: April 26, 2021
• Recall Status: Terminated on July 12, 2022
• Recall Number: Z-1496-2021
• Recall Event ID: 87683
• 510(K)Number: K052202 K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.; Model Numbers:; System Material #; AXIOM Artis FC 05904433;; AXIOM Artis FA 05904441;; AXIOM Artis MP 05904466;; AXIOM Artis BC 05904649;; AXIOM Artis BA 05904656;; AXIOM Artis dBC Mag. Nav. 05917054;; AXIOM Artis TA 07007755;; AXIOM Artis dTA 07008605;; AXIOM Artis dFC 07412807;; AXIOM Artis dTC 07413078;; AXIOM Artis dBA 07555357;; AXIOM Artis dMP 07555365;; AXIOM Artis dFA 07555373;; AXIOM Artis dFC Mag. Nav. 07727717;; AXIOM Artis TC 07728350;; AXIOM Artis dBC 07728392;; Artis zee floor 10094135;; Artis zee ceiling 10094137;; Artis zee MP 10094139;; Artis zee biplane 10094141;; Artis zee floor MN 10094142;; Artis zee biplane MN 10094143;; Artis Q floor 10848280;; Artis Q ceiling 10848281;; Artis Q biplane 10848282;; Artis Q.zen floor 10848353;; Artis Q.zen ceiling 10848354;; Artis Q.zen biplane 10848355.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
• FDA Determined Cause: Equipment maintenance
• Action: Siemens Medical Solutions USA, Inc. issued Urgent Medical Device Correction dated 3/303/21 (AX068/20/S). The letter states reason for recall, health risk and action to take: Use only recommended substances for cleaning and disinfection. Do not let cleaning liquids seep into the openings of the system, e.g., air openings, gaps between covers. Observe the attached cleaning and disinfection instructions. An addendum to the system Operator Manual explaining appropriate cleaning in detail has been released via Update Instruction AX068/20/S and is attached to this letter. This letter and the attached addendum should both be filed with the system documentation. Please feel free to contact our service organization at 1-800-888-7436 should you have any questions. The addendum will increase awareness concerning the cleaning process and mitigate the occurrence of the potential issue. There are no risks for patients who have previously been examined or treated. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. Promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.
• Quantity in Commerce: 3,320 units U.S.
• 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 Solution USA, Inc.; 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.