Biograph 16 TruePoint, MATERIAL NUMBER 10249555 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: 72402,72404,72407,72414,72419,72420,72421,72427,72429,72431,72433,72434,72435,72436,72437,72440,72441,72443,72444,72445,72448,72450,72453,72455,72457,72459,72460,72461,72464,72465,72466,72468,72471,72472,72475,72476,72477,72481,72486,72487,72489,72491,72492,72494,72495, 72496,72497,72499,72501,72502,72503,72504,72505,72512,72515,72521,72523,72526,72528,72530,72531,72535,72537
- 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.
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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 16 TruePoint, MATERIAL NUMBER 10249555 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: 72402,72404,72407,72414,72419,72420,72421,72427,72429,72431,72433,72434,72435,72436,72437,72440,72441,72443,72444,72445,72448,72450,72453,72455,72457,72459,72460,72461,72464,72465,72466,72468,72471,72472,72475,72476,72477,72481,72486,72487,72489,72491,72492,72494,72495, 72496,72497,72499,72501,72502,72503,72504,72505,72512,72515,72521,72523,72526,72528,72530,72531,72535,72537
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2037-2016
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