FDAFDA · Food and drugs·Recall number Z-2025-2016
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.
Published June 29, 2016 · Recall initiated: April 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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