FDA Device recall Z-2025-2016
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
- FDA Device
- Class II
- terminated
- Published 2016-06-29
On 2016-06-29 the FDA classified a Class II recall of BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po… by Siemens Medical Solutions Usa, citing siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2025-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-22 |
| Published | 2016-06-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Identifiers
| code_info | Serial Numbers: 11002,11003,11004,11001,11005,11006,11008,11009,11007,11010,11011,11012,11014,11015,11013,11017,11016,…Serial Numbers: 11002,11003,11004,11001,11005,11006,11008,11009,11007,11010,11011,11012,11014,11015,11013,11017,11016,11021,11018,11019,11025,11023,11022,60001,11026 |
|---|
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-2025-2016%22
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