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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Force

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 Class 2 Device Recall SOMATOM Forcesee related information
Date Initiated by FirmDecember 03, 2014
Date PostedJanuary 14, 2015
Recall Status1 Terminated 3 on April 06, 2015
Recall NumberZ-0971-2015
Recall Event ID 69957
510(K)NumberK133589 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Code Information Model number: 10742326, serial numbers 75437, 75454, 75464, 75450, 75467, 75475, 75439. 
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information ContactCustomer Support
610-219-6300
Manufacturer Reason
for Recall		Artifacts are found in acquired imaging on the SOMATOM Force.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionA customer advisory notice, dated December 3, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were informed that new software would be installed via remote access.
Quantity in Commerce7
DistributionPA, MA, MN, SC, MD, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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