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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCT Flow 404R

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  Class 2 Device Recall Biograph mCT Flow 404R see related information
Date Initiated by Firm November 13, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on July 09, 2015
Recall Number Z-0808-2015
Recall Event ID 69897
510(K)Number K123737  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Biograph mCT Flow 40-4R, System Material Number 10529159.

The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Code Information Serial Number: 11002
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact Jeffrey Bell
865-218-2000
Manufacturer Reason
for Recall		 Possibility for system display freeze during CT interventional procedures.
FDA Determined
Cause 2		 Software design
Action The firm initiated their recall by certified mail on 11/13/2014.
Quantity in Commerce 1 unit
Distribution Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
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 = KPS and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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