Siemens Medical Solutions USA Inc. Recall: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 105291
Siemens Medical Solutions USA Inc. Recall: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 105291 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Medical Solutions USA Inc.; Product: BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined
| Recalling firm | Siemens Medical Solutions USA Inc. |
|---|---|
| Product | BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint 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. |
| Reason for recall | Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide |
| Recall initiated | 20160422 |
| Recall number | Z-2025-2016 |
| Category | device |
| State | TN |
| Country | United States |
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