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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Pheno (VE2)

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  Class 2 Device Recall ARTIS Pheno (VE2) see related information
Date Initiated by Firm February 25, 2022
Create Date April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0987-2022
Recall Event ID 89870
510(K)Number K201156  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures.
Model: 10849000
Code Information Serial Number:  164719 164712 164740 164722 164763 164735 164723 164743 164741 164728 164711 164718 164739 164703 164721 164726 164724 164725 164760  UDI: 04056869046877
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		 Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
FDA Determined
Cause 2		 Software Design Change
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to all affected customers via AX005/22/S on 2/28/22. Siemens will provide a software update for all affected systems via Update Instruction AX003/22/S and AX004/22/S. Letter states reason for recall, health risk and action to take: We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 5) 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 AX003/22/S and Update Instruction AX004/22/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice 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. If you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this notification via Certified Mail, please provide at least two contact names and email addresses of the appropriate personnel within your facility who should receive these notifications electronically. This information will assist in providing you with these important notifications in a more expedient and compliant manner. Please include your Siemens system names, material numbers, serial numbers, and Siemens Functional Location numbers and email this information to: recallsandrefusals.team@siemens-hea
Quantity in Commerce 20 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 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.
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