Canon Medical System, USA, INC.: Medical Device Recall in 2026 - (Recall #: Z-1178-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Alphenix INFX-8000H, interventional fluoroscopic x-ray system

Product Classification:

Class II

Date Initiated: December 19, 2025

Date Posted: February 4, 2026

Recall Number: Z-1178-2026

Event ID: 97970

Reason for Recall:

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

Status: Ongoing

Product Quantity: 3 units

Code Information:

serial numbers: D2A1672385, A2A20Z2165, B2A1692426.

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Dominican Republic.

Voluntary or Mandated:

Voluntary: Firm initiated