Reported Jun 27, 2018 · Terminated
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc. · 2501 Barrington Rd · Hoffman Estates, IL · 60192-2061
Is this the product you have?
- Biograph mCT Systems(a) Biograph mCT S(64)-3R
- Material Number 10248669 Product UsageThe 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. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
- Lot codes and dates
(a) Biograph mCT S(64)-3RMaterial Number 10248669
- Serial Numbers(b) Biograph mCT S(40)-4R, Material Number 10248671
100611025110151102111012110161101910031004110101101411032100511027110171102211033110201101121036110181100911013110231102411026110281102911030110312103431055
- Serial Numbers(c) Biograph mCT S(64)-4R, Material Number 10248672
87 of 87 codes
110431104511046110721105811069101311081110571002100810111019110371104011067110731003100710171102911032110511105411061110621106311080110531001110771025110331104911084210872109110121014110391105511056110591107511078210852108921090101811036100511038110471106411065210861103111028110701020
- Serial Numbers(d) Biograph mCT X-4R, Material Number 10248670
102 of 102 codes
1004110461106411036110301109311033110321104111042110431104411047110531106911071110781107911084110821109111092210982110121102211052110410161102411026110291105411058110771108611095110521106811096110201106711087110151006101911073110751108321097110882110310101103811039110401106111062110631107611081
- Serial Numbers(e) Biograph mCT X-3R, Material Number 10248673
71 of 71 codes
100811016110171102211029110361105411066101010041106311027110551105611058110571106011064110702107410031005100911015110231103711042110451104711052110591106511031100211061110681006110191104111048110381103911014110211102811030110341106921071110181101311040110671102511049110511105011046110621007
- Serial Numbers(f) BIOGRAPH mCT 20 Excel, Material Number 10507786
1101011013110111100910061002100711012110151101711016100310041005110201100811019
- Serial Numbers(g) Biograph mCT Flow Edge-4R, Material Number 10528955
110131100111022110261103211007110121103811002110061101411015110191102011035110371104611034110241103611049110501100911027110281100311004110081101011017110181102111023110251102911030110311103311039110401104111042110431104411045110472105121119
- Serial Numbers
11001 (h) Biograph mCT S(40)-3RMaterial Number 10248668
- Serial Numbers(i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743
210481104411024110341002110181102511032110291103910041013101710101102711022100711019100611036100510121014101510161102311026110281103011031110381104011041110422104511037
- Serial Numbers
1002 (j) Biograph mCT Flow 40-4RMaterial Number 10529159
- Serial Numbers
11001 (k) Biograph mCT-X w/TrueV UpgradeMaterial Number 10250745
- Serial Numbers1001
- Amount recalled
- 405 units
Why it was recalled
Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph mCT Flow systems.
This product could cause temporary or reversible health problems — stop using it.
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