FDA recall Z-0284-2025

Canon Medical System, USA, INC. · Class II · device

Product

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.

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

Key facts

Status
Ongoing
Initiation date
2024-09-17
Report date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0284-2025