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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Emotion 6

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 Class 2 Device Recall SOMATOM Emotion 6see related information
Date Initiated by FirmApril 20, 2015
Date PostedMay 22, 2015
Recall Status1 Terminated 3 on September 01, 2016
Recall NumberZ-1644-2015
Recall Event ID 71101
510(K)NumberK133424 
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Emotion 6; 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 SOMATOM Emotion 6 (2007) - 10165888   with serial numbers: 29338 27232 27230 27231 
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		Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
FDA Determined
Cause 2		Software design
ActionSiemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
Quantity in Commerce75
DistributionNationwide Distribution including Puerto Rico.
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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