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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Emotion 6 (Model 10165888)

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 Class 2 Device Recall SOMATOM Emotion 6 (Model 10165888)see related information
Date Initiated by FirmFebruary 01, 2018
Date PostedMarch 30, 2018
Recall Status1 Terminated 3 on May 01, 2020
Recall NumberZ-2472-2018
Recall Event ID 79665
510(K)NumberK023687 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductSOMATOM Emotion 6 (Model 10165888)
Code Information Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMarlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		A potential risk of unnecessary radiation exposure due to a software issue
FDA Determined
Cause 2		Software design
ActionCustomers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
DistributionNationwide
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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