| Class 2 Device Recall BIOGRAPH 40 TruePoint | |
Date Initiated by Firm | April 22, 2016 |
Date Posted | June 21, 2016 |
Recall Status1 |
Terminated 3 on May 08, 2017 |
Recall Number | Z-2008-2016 |
Recall Event ID |
74192 |
510(K)Number | K141971 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | BIOGRAPH 40 TruePoint, Material Number 10097303
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: 1003,1004,1005,1006,1009,1011,1012,1013,1014,1015,1016,1017,1018,1019,1020,1022,1023,1024,1028,1029,1030,1031,1032,1033,1034,1035,1036,1037,1039,1041,1042,1043,1044,1045,1046,1047,1049,1050,1051,1052,1053,1054,11055,11056,11059,11060,11061,11063 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
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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 | 48 units |
Distribution | Worldwide Distribution - US Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KPS
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