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
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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
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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 |
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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 510(K)s with Product Code = JAK 510(K)s with Product Code = JAK
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