Class 2 Device Recall Siemens

• Date Initiated by Firm: August 30, 2021
• Create Date: November 24, 2021
• Recall Status: Terminated on January 16, 2024
• Recall Number: Z-0289-2022
• Recall Event ID: 88888
• 510(K)Number: K190578
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
• Code Information: Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004
• 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: software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
• FDA Determined Cause: Software design
• Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (CSAN) to customers via CT021/21/S on 8/30/2021. The CSAN informs the customer of the issues health risk, the new software update version VB20_SP5 to eliminate the root causes of these problems. The software update will be distributed free of charge via CT020/21/S and CT071/21/S (update is dependent on the current software version) to all affected customers. Action to take: Siemens Healthineers has developed software update syngo.CT VB20 SP5. This new software contains workflow improvements and solutions to the previously described software issues. Please ask your local service organization if you are interested in more detailed information about the content of the software update. The new software, VB20_SP5, will be provided free of charge and will be distributed via Update CT020/21/S or CT071/20/S. Update CT071/20/S is only necessary if the system is being updated from software version VB20, VB20_SP1, or VB20_SP2 directly to VB20_SP5. Following the corrective action process CAPA, the cause of identified product issues has been eliminated and a recurrence of the identified issues is prevented. This update will be performed remotely. The remote software updates process will require approximately 45 minutes for completion and is completely automatic; however, please make sure the system and power are stable before and during the process, please do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If you have any questions, please contact our service organization at 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: 64 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 = JAK