Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Biograph Horizon Recalled by Siemens Medical Solutions USA, Inc. Due to Possibility that the Biograph Horizon systems performing CT...
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 Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Quantity: 14 units
Why Was This Recalled?
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Where Was This Sold?
Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
About Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc. has 87 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report