Class 2 Device Recall Siemens Artis Icono Biplane

• Date Initiated by Firm: October 12, 2021
• Create Date: January 21, 2022
• Recall Status: Terminated on April 11, 2024
• Recall Number: Z-0516-2022
• Recall Event ID: 89260
• 510(K)Number: K193326
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis icono biplane with software VE20C-diagnostic imaging angiography system; Model: 11327600
• Code Information: Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: SAME; 610-219-4834
• Manufacturer Reason for Recall: Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
• FDA Determined Cause: Software design
• Action: Siemens issued A Customer Safety Advisory Notice dated 10/12/21 to affected customers via AX047/21/S. Additionally, a software update will be initiated for all affected users via Update Instruction AX046/21/S. Letter states reason for recall, health risk and action to take: To avoid inaccurate measurement values, repeat the distance measurements after changing the Auto TOD Calibration or Distance Calibration of the scene. Additionally, before closing the image after performing the calibration, create a screenshot/secondary capture image for post review. The Operator Manual of the affected systems will be updated according to the information mentioned above. This is regarded as an interim solution until the next software update is available. The Operator Manual update will draw attention to the issue. We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 4) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable. Siemens will correct the software error via Update Instruction AX046/21/S. 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.
• Quantity in Commerce: 72 units
• 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.