Date Initiated by Firm | July 13, 2016 |
Date Posted | August 23, 2016 |
Recall Status1 |
Terminated 3 on January 24, 2017 |
Recall Number | Z-2625-2016 |
Recall Event ID |
74840 |
510(K)Number | K143416 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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Product | SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system |
Code Information |
Model # 10590000 Serial # 83398, and 83387 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
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For Additional Information Contact | Meredith Adams 610-448-6461 |
Manufacturer Reason for Recall | Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector. |
FDA Determined Cause 2 | Software in the Use Environment |
Action | Siemens mailed to customers an Important Customer Safety Notice to inform about a possible malfunction when using the affected systems and what actions to take to eliminate the problem. Also, Siemens informed their customers that they were currently developing a new firmware to eliminate the internal communication error, which should be released in August 2016. Customers were asked to contact their service organization at 800-888-7436, if they had any questions. |
Quantity in Commerce | 2 systems |
Distribution | Distributed to: MI, NY, CA, KY, ND, NE |
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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