| Date Initiated by Firm | March 03, 2021 |
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| Create Date | March 15, 2021 |
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| Recall Status1 |
Terminated 3 on December 28, 2023 |
| Recall Number | Z-1253-2021 |
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| Recall Event ID |
87454 |
| 510(K)Number | K163296 K173632 K192061 K200524 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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| Product | Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows:
SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628)
SOMATOM go.All (Model 11061630)
SOMATOM go.Top (Models 11061640 & 11061648)
SOMATOM go.Sim (Model 11061660)
SOMATOM go.Open Pro (Model 11061670)
SOMATOM X.cite (Model 11330001) |
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| Code Information |
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a |
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
|
| For Additional Information Contact | SAME
610-219-4834 |
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Manufacturer Reason
for Recall | SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result |
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FDA Determined
Cause 2 | Software design |
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| Action | Siemens Medical Solutions USA, Inc., provided Customer Information Letter on 3/3/21 to affected customers via CT063/20/S. Customers with valid email addresses emailed a copy of the CSAN via Adobe Mega Sign. The CSAN will be distributed to the remaining customers address via hand delivery by the Siemens Customer Service Engineer. The letter states reason for recall, health risk and action to take:
Siemens Healthineers has developed software update syngo.CT VA30A_SP3 to ensure uninterrupted scanning workflows and to reduce the number of user notifications. This update will also provide improvements related to the general system, examination and reconstruction processes, as well as improvements for dual energy post-processing.
Following the corrective action, the cause has been eliminated and recurrence of the identified issues are prevented. This software update will be provided to you free of charge.
How will the corrective action be implemented?
Software update CT084/20/S will be performed onsite for SOMATOM X.cite (Model #11330001). For all other systems, the update CT064/20/S will be performed remotely.
The remote software updates process will require approximately 180 minutes for completion.
If you have any unresolved questions or you require technical support, please contact your local application specialists or your local service/sales organization at 1-800-888-7436. |
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| Quantity in Commerce | 190 units US |
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| Distribution | US Nationwide distribution. |
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| 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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