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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Artis

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  Class 2 Device Recall Siemens Artis see related information
Date Initiated by Firm June 30, 2021
Create Date September 02, 2021
Recall Status1 Open3, Classified
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/
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
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 2
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Siemens Medical Solution USA, Inc.