Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 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: 1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022, 1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040, 11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046
- 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 mCT-S(40) 3R, MATERIAL NUMBER 10248668 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: 1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022, 1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040, 11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2030-2016
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