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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens SOMATOM Force

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  Class 2 Device Recall Siemens SOMATOM Force see related information
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 and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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