Class 2 Device Recall SOMATOM

• Date Initiated by Firm: June 04, 2019
• Create Date: July 02, 2019
• Recall Status: Terminated on March 29, 2023
• Recall Number: Z-1919-2019
• Recall Event ID: 83112
• 510(K)Number: K173632
• Product Classification: System, x-ray, tomography, computed - Product Code JAK
• Product: SOMATOM go.Up, Model No. 11061628; ; with syngo.CT software versions VA20A,; VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.
• Code Information: 108128 108101 108158 108164 108118 108112 108163 108183 108133 108170 108096 108114 108154 108168 108144 108120 108136 108174 108106 108099 108113 108177 108080 108126 108153 108088 108085 108115 108100 108175 108076 108109 108127 108108 108176 108059 108054 108179 108125 108116 108056 108077 108155 108069 108146 108062 108130 108095 108111
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Rebecca Tudor; 610-219-4834
• Manufacturer Reason for Recall: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
• FDA Determined Cause: Software design
• Action: On June 4, 2019, the firm notified customers of the recall via Urgent Medical Device Correction letters. Customers were informed that the firm has developed software update CT VA20A-SP2A to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also improve some areas during the start-up and shut-down processes, as well as providing other improvements related to the system, examination and reconstruction processes, and dual energy and intervention . The corrective action will be provided free of charge and will be distributed via Update Instruction CT026/19P. This update will be performed remotely. If you have any questions, please contact our service organization at 1- 800-888-7436. Customers were asked to promptly notify and instruct all staff at their organizations who need to be aware of this notice. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product advisory notice. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner.
• Quantity in Commerce: 69
• Distribution: US Nationwide distribution in the states of AL CA CT FL GA IL IN KS KY LA ME MI MO MS NC ND NE NH NY OH OK SD TN TX VA and 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 = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.