Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biograph 16 TruePoint Recalled by Siemens Medical Solutions USA Inc. Due to Siemens Medical Solutions, Molecular Imaging has become aware...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA Inc. directly.
Affected Products
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.
Quantity: 63 units
Why Was This Recalled?
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions USA Inc.
Siemens Medical Solutions USA Inc. has 65 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report