Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cartesion Prime Recalled by Canon Medical System, USA, INC. Due to When PET-CT system is executing reconstruction, if PET...
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 Canon Medical System, USA, INC. directly.
Affected Products
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Quantity: 27
Why Was This Recalled?
When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
Where Was This Sold?
This product was distributed to 18 states: AL, AZ, AR, CA, CO, IL, IN, IA, KS, LA, MD, MN, MS, NV, NC, TN, VA, WI
About Canon Medical System, USA, INC.
Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report