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U.S. Department of Health and Human Services

Class 2 Device Recall Biograph mCT S(64)4R

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  Class 2 Device Recall Biograph mCT S(64)4R see related information
Date Initiated by Firm December 13, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-0996-2017
Recall Event ID 76127
510(K)Number K151486  
Product Classification System, tomography, computed, emission - Product Code KPS
Product Biograph mCT S(64)-4R, Material Number 10248672
The Siemens Biograph mCT and Biograph mCT Flow 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. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Code Information Serial Numbers: 1004, 11046, 11064, 11036, 11030, 11093, 11033, 11032, 11041, 11042, 11043, 11044, 11047, 11053, 11069, 11071, 11078, 11079, 11084, 11082, 11091, 11092, 21098, 21101, 21102, 21105, 21104, 1016, 11024, 11026, 11029, 11054, 11058, 11077, 11086, 11095, 11052, 11068, 11096, 11020, 11067, 11087, 11015, 1006, 1019, 11073, 11075, 11083, 21097, 11088, 21103, 1010, 11039, 11040, 11061, 11062, 11063, 11076, 11081, 21100, 11025, 11051, 11065, 11070, 11072, 11050, 11023, 1005, 11074, 11094, 1012, 11059, 11045, 1002, 1003, 1007, 1011, 1014, 1013, 1018, 11022, 11021, 11027, 11028, 11031, 11034, 11035, 11037, 11048, 11049, 11055, 11056, 11057, 11060, 11066, 11080, 11089, 11090, 21099, 1001, 1001
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA Inc.
810 Innovation Dr
Knoxville TN 37932-2562
For Additional Information Contact
865-218-2000
Manufacturer Reason
for Recall		 Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
FDA Determined
Cause 2		 Device Design
Action Siemens Healthineers sent a Customer Safety Advisory Notice letter on December 13, 2016. The letter states that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out and warning the consignee not to use the system of the front cover is loose or missing. Customers with questions were instructed to contact their local Siemens representative at the following numbers: America 1-800-888-7436 Europe, Middle East and Africa +49 9131 940 4000 Asia and Australia +86 (21) 3811 2121 For questions regarding this recall call 865-218-2000.
Quantity in Commerce 102 units
Distribution Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO RU, SE, SG, SI, SK, TH, TR, AND TW.
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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