Canon Medical System, USA, INC.: Medical Device Recall in 2022 - (Recall #: Z-1666-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

INFX-8000V. For radiographic and fluoroscopic studies and intervention.

Product Classification:

Class II

Date Initiated: January 31, 2022

Date Posted: September 7, 2022

Recall Number: Z-1666-2022

Event ID: 90737

Reason for Recall:

The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.

Status: Ongoing

Product Quantity: 16 systems

Code Information:

Model: Alphenix i with software version 8.0, 9.0 or 9.2 and the TFP 1200C FPD.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated