The FDA has posted 8 enforcement recalls from Canon Medical System, USA, INC. since 2025, none of them Class I (most serious). Most recent report: Feb 4, 2026.
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.…
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.…
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.…
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.…
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems.…
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems.…
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.
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimate…
Firm name as filed with the FDA: “Canon Medical System, USA, INC.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.