Canon Medical System, USA, INC.: Medical Device Recall in 2021 - (Recall #: Z-1175-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

System INFX-8000C

Product Classification:

Class II

Date Initiated: February 5, 2021

Date Posted: March 17, 2021

Recall Number: Z-1175-2021

Event ID: 87419

Reason for Recall:

The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.

Status: Ongoing

Product Quantity: 272 in total

Code Information:

Model: CAS-880A, CAS-830B

Distribution Pattern:

Nationwide

Voluntary or Mandated:

FDA Mandated