Canon Medical System, USA, INC.: Device Recall

Recall Details

Recall Number

Z-0284-2025

Classification

Class II

Product Type

Device

Recalling Firm

Canon Medical System, USA, INC.

Status

Ongoing

Date Initiated

09/17/2024

Location

Tustin, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

27

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.

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.

Distribution Pattern

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

Other Recalls by Canon Medical System, USA, INC.

• Class II: Risk 12/19/2025
  There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
• Class II: Risk 12/19/2025
  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
• Class II: Risk 12/19/2025
  There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
• Class II: Risk 12/19/2025
  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
• Class II: Risk 12/19/2025
  It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

View all recalls by Canon Medical System, USA, INC. →