Siemens Medical Solutions USA Inc. recalls Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray C…

Recall date

December 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0994-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA Inc.

Sold / distributed

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.

Why it was recalled

Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Biograph mCT X-4R, Material Number 10248670 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.