BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 1002,1003,1004,1005,1006,1007,1008,1011,1013,1014,1015,1016,1017,1019,1020,1021,1022,1023,1024,1025,1028,1029,1030,1031,1032,1033,1034,1036,1037,1038,1039,1041,1042,1043,1045,1046,1048,1049,1050,1051,1052,1054,1055,11057,11059,11060,11061,11063,58004
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA Inc.
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 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.
Product Codes/Lot Numbers:
Serial Numbers: 1002,1003,1004,1005,1006,1007,1008,1011,1013,1014,1015,1016,1017,1019,1020,1021,1022,1023,1024,1025,1028,1029,1030,1031,1032,1033,1034,1036,1037,1038,1039,1041,1042,1043,1045,1046,1048,1049,1050,1051,1052,1054,1055,11057,11059,11060,11061,11063,58004
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2015-2016
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.