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U.S. Department of Health and Human Services

Class 2 Device Recall BIOGRAPH Sys 403R to 404R

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 Class 2 Device Recall BIOGRAPH Sys 403R to 404Rsee related information
Date Initiated by FirmApril 22, 2016
Date PostedJune 21, 2016
Recall Status1 Terminated 3 on May 08, 2017
Recall NumberZ-2018-2016
Recall Event ID 74192
510(K)NumberK141971 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductBIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 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: 1001,1003,1010,11012
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contactsee 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
ActionSiemens 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 Commerce4 units
DistributionWorldwide Distribution - US Nationwide
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 = KPS
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