Medical Device Recall: 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.
Canon Medical System, USA, INC. · September 17, 2024
Reason for Recall
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.
Distribution
US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
States Affected
AL, AR, AZ, CA, CO, IA, IL, IN, KS, LA, MD, MN, MS, NC, NV, TN, VA, WI
Quantity Affected
27
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0284-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.