Recall Z-0284-2025— Canon Medical System, USA, INC.

Name: FDA recall Z-0284-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-17

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2024-09-17. It names one FDA 510(k) clearance: K231748. 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: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2024-09-17
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K231748 — Cartesion Prime (PCD-1000A/3) V10.15Canon Medical Systems Corporation·cleared 2023-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.