Canon Medical System, USA, INC.: Medical Device Recall in 2025 - (Recall #: Z-0327-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Product Classification:

Class II

Date Initiated: October 16, 2025

Date Posted: November 5, 2025

Recall Number: Z-0327-2026

Event ID: 97735

Reason for Recall:

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

Status: Ongoing

Product Quantity: 2 units

Code Information:

CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

Distribution Pattern:

US distribution to Ohio and Nevada

Voluntary or Mandated:

Voluntary: Firm initiated