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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Definition AS

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  Class 2 Device Recall SOMATOM Definition AS see related information
Date Initiated by Firm July 13, 2016
Date Posted August 23, 2016
Recall Status1 Terminated 3 on January 24, 2017
Recall Number Z-2624-2016
Recall Event ID 74840
510(K)Number K143409  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Code Information Model # 10430603 Serial # 74192
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
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 1 unit
Distribution Distributed to: MI, NY, CA, KY, ND, NE
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 and Original Applicant = Siemens Medical Solutions USA, Inc.
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