Date Initiated by Firm | February 15, 2018 |
Create Date | April 30, 2018 |
Recall Status1 |
Terminated 3 on April 08, 2020 |
Recall Number | Z-1453-2018 |
Recall Event ID |
79428 |
510(K)Number | K050297 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM Sensation 10
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. |
Code Information |
7543015 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact | 610-219-4834 |
Manufacturer Reason for Recall | to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure |
FDA Determined Cause 2 | Software design |
Action | The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1301 units will consist of the following:
1. You will contact customers and initiate the actions to correct the failure to comply issue.
2. You will provide a software update to correct tube current calculations by the CARE Dose4D algorithm for head scans.
3. You will follow-up with consignees to verify the effectiveness of the software update.
CDRH approves the CAP subject to the following conditions:
1.Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
You may proceed or continue with implementation of the CAP (subject to the conditions noted above). For further questions, please call (610) 219-4834. |
Quantity in Commerce | 1301 |
Distribution | USA (nationally) 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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