Canon Medical System, USA, INC. recalls Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Po…

Recall date

September 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0284-2025

FDA classification

Class II

Brand / firm

Canon Medical System, USA, INC.

Sold / distributed

US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.