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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCTX 3R

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  Class 2 Device Recall Biograph mCTX 3R see related information
Date Initiated by Firm April 22, 2016
Date Posted June 21, 2016
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-2034-2016
Recall Event ID 74192
510(K)Number K141971  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Biograph mCT-X 3R, MATERIAL NUMBER 10248673

The Siemens Biograph TruePoint 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 Numbers: 1002,1003,1004,1005,1006,1007,11009,11010,11011,11012,11008,11013,11015,11019,11017,11018,11020,31021,31022,31023,11014,1001 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact see comments
865-218-2000
Manufacturer Reason
for Recall		 Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.
Quantity in Commerce 22 units
Distribution Worldwide Distribution - US Nationwide
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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