Date Initiated by Firm | July 03, 2019 |
Create Date | August 14, 2019 |
Recall Status1 |
Terminated 3 on May 10, 2024 |
Recall Number | Z-2272-2019 |
Recall Event ID |
83377 |
510(K)Number | K162302 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems 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. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies). |
Code Information |
Serial Numbers: 100172 100091 100112 100143 100158 100191 100107 100157 100137 100190 100092 100129 100136 100189 100156 100117 100097 100099 100174 100073 100016 100182 100146 100170 100175 100090 100160 100087 100025 100165 100147 100046 100140 100085 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | 610-219-4834 |
Manufacturer Reason for Recall | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. |
FDA Determined Cause 2 | Software design |
Action | Siemens has initiated a Customer Safety Advisory Notice (CSAN) to all affected customers via CT035/19/S. Customers with valid email addresses were emailed a copy of the CSAN on 07/03/2019 via Adobe Mega Sign. The CSAN were distributed to the remaining customers without a valid email address via certified mail on 07/12/2019. Additionally, a solution to eliminate the root cause of this problem (application of software update VB20) will be distributed to all affected customers free of charge. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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