Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biograph 16 TruePoint TrueV - 4R Recalled by Siemens Medical Solutions USA Inc. Due to The mobile-specific instructions was not shipped to a...
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 TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Quantity: 4 units
Why Was This Recalled?
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
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