FDAFDA · Food and drugs·Recall number Z-2032-2016
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 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: 1003,1004,1005,1006,1007,11009,11010,11011,11012,11013,11014,11023,11015,11016,11017,11018,11019,11020,11021,11022,11025,11028,11029,11027,31042,11024,11026,11033,11032,21034,31037,31040,21035,11031,11030,21036,31038,31039,31046,31041,31043,31045,31047,31048,31044,31049, 31050,31051,31054,1008,31053
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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