Class 2 Device Recall Siemens Artis

• Date Initiated by Firm: June 30, 2021
• Create Date: September 02, 2021
• Recall Status: Terminated on February 10, 2023
• Recall Number: Z-2404-2021
• Recall Event ID: 88412
• 510(K)Number: K181407
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 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 Angiography systems developed for single and biplane diagnostic imaging
• Code Information: Units with SW version VD12 Serial Numbers: 104005 104007 104012 104013 105500 105501 109645 110001 110005 110006 110007 110014 110016 110017 110018 110022 110023 110024 110025 110026 110027 110031 110032 110035 110036 110037 110039 110040 110041 110042 110043 110044 110046 110048 110051 111133 111500 111501 111502 111503 111504 111505 111506 111507 111508 111510 122001 122002 122005 122007 123501 123502 139012 150002 150003 150005 150009 150011 159010 159015 159021 159024 159025 159026 159028 159030 159032 159034 159037 159038
• 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 a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
• FDA Determined Cause: Software design
• Action: Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to affected customers via AX045/21/S dated 6/30/21. Letter states reason for recall, health risk and action to take: If the BYPASS/ BYPASS FLUORO message does not disappear after approximately four minutes, an additional restart of the Artis system is necessary. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will provide a software update for all affected systems via Update Instruction AX044/21/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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.
• Quantity in Commerce: 70 US (172 WW)
• Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.
• 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