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U.S. Department of Health and Human Services

Class 2 Device Recall Computed tomography xray system

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  Class 2 Device Recall Computed tomography xray system see related information
Date Initiated by Firm November 24, 2020
Create Date January 09, 2021
Recall Status1 Terminated 3 on February 06, 2024
Recall Number Z-0771-2021
Recall Event ID 87079
510(K)Number K103127  K121072  K133589  K142955  K161196  K173607  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Force, Definition AS, Definition Edge, Definition Flash,
Drive, Confidence and Edge Plus
Code Information SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact Rebecca Tudor
610-219-4834
Manufacturer Reason
for Recall		 System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
FDA Determined
Cause 2		 Software design
Action Customer notification letters will be sent starting December 14, 2020 to all affected customers via Customer Advisory Notice CT057/20/S. The technical solution, software versionVB20A_SP3, will be distributed to all affected customers free of charge via CT056/20/S. For questions or technical support, contact your local application specialists or your local service/sales organization at 1-800-888-7436.
Quantity in Commerce 3044
Distribution US Nationwide
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.
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
510(K)s with Product Code = JAK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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