Date Initiated by Firm | August 18, 2015 |
Date Posted | October 06, 2015 |
Recall Status1 |
Terminated 3 on May 08, 2017 |
Recall Number | Z-0107-2016 |
Recall Event ID |
72137 |
510(K)Number | K133589 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | SOMATOM Force; computed tomography x-ray system.
Intended to generate and process cross-sectional images of patients. |
Code Information |
Model Number of device- 10742326 with serial numbers: 75514 75512 75510 75454 75437 75500 75475 75481 75439 75450 75482 75460 75493 75476 75458 75467 75487 75478 75513 75515, and 75501. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | Software and firmware bugs |
FDA Determined Cause 2 | Software design |
Action | Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner. |
Quantity in Commerce | 21 |
Distribution | Nationwide Distribution |
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
|