Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flo...
FDA Device Recall #Z-1002-2017 — Class II — December 13, 2016
Recall Summary
| Recall Number | Z-1002-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 13, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA Inc. |
| Location | Knoxville, TN |
| Product Type | Devices |
| Quantity | 1 unit |
Product Description
Biograph mCT Flow 40-4R, Material Number 10529159 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 for Recall
Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
Distribution Pattern
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.
Lot / Code Information
Serial Numbers: 11001
Other Recalls from Siemens Medical Solutions USA Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1424-2017 | Class II | Biograph 16 TruePoint - 3R, Material Number 102... | Feb 20, 2017 |
| Z-1425-2017 | Class II | Biograph 16 TruePoint TrueV - 4R, Material Numb... | Feb 20, 2017 |
| Z-1422-2017 | Class II | Biograph 6 TruePoint, Material Number 10097289 ... | Feb 20, 2017 |
| Z-1423-2017 | Class II | Biograph 6 TruePoint, Material Number 10097290 ... | Feb 20, 2017 |
| Z-0999-2017 | Class II | Biograph mCT-X w/TrueV Upgrade, Material Number... | Dec 13, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.