Date Initiated by Firm | February 14, 2019 |
Create Date | May 03, 2019 |
Recall Status1 |
Terminated 3 on May 01, 2020 |
Recall Number | Z-1246-2019 |
Recall Event ID |
82227 |
510(K)Number | K173607 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM Edge Plus, Model Number 10267000
Product Usage:
Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. |
Code Information |
Serial numbers of all affected models: 122022 100143 100107 83834 83746 83811 66649 122020 83801 122008 122029 83767 83852 100092 83798 100091 100112 100129 100136 83837 122023 83871 100117 100097 100099 122009 83763 83819 83752 83845 83846 83749 83847 100146 83786 83842 83775 100090 83796 83768 83859 100087 83826 83754 83790 122011 83824 100147 83810 83758 100140 100085 83808 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | SAME 610-219-4834 |
Manufacturer Reason for Recall | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube. |
FDA Determined Cause 2 | Software design |
Action | Siemens issued letter dated 2/14/19 providing reason for recall and a user workaround in the Customer Safety Advisory Notice (CSAN) CT006/19/S. The recall issue will be permanently resolved by software update syngo CT VB10A_SP1. Contact the service organization 1-800-888-7436. |
Quantity in Commerce | 53 total units distributed in U.S. |
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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