FDA Device recall Z-0993-2017
Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp… by Siemens Medical Solutions Usa, citing siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0993-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-13 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Biograph mCT S(64)-3R, Material Number 10248669 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.
Reason
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Identifiers
| code_info | Serial Numbers: 1006, 11025, 11015, 11021, 11012, 11016, 11019, 1003, 1004, 11010, 11014, 11032, 1005, 11027, 11017, 1…Serial Numbers: 1006, 11025, 11015, 11021, 11012, 11016, 11019, 1003, 1004, 11010, 11014, 11032, 1005, 11027, 11017, 11022, 11033, 11020, 11011, 21036, 11018, 11009, 11013, 11023, 11024, 11026, 11028, 11029, 11030, 11031, 21034, 31055 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0993-2017%22
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