Recall Weekly
Moderate riskFDA DeviceClass II

Canon Medical Alphenix INFX-8000H X-ray system recalled for loose ceiling suspension screws

Fixing screws on the ceiling-mounted arm of certain Canon Medical Alphenix X-ray systems may become loose. This can prevent the arm from moving side to side, cause unusual noise, or trigger error messages. Three units worldwide are affected.

From the FDA notice · Read the official notice ↗ · All Canon recalls

What to do

  1. If you operate an Alphenix INFX-8000H system, check its serial number against the affected list: D2A1672385, A2A20Z2165, B2A1692426
  2. Contact Canon Medical System, USA, Inc. immediately if your system's serial number matches
  3. Do not operate the system if you notice abnormal noise or movement limitations until screws are inspected and tightened
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
3 units
Illnesses reported
None reported
Manufactured in
2441 Michelle Dr, N/A, Tustin, CA, United States
Classification
Class II
Recall number
Z-1178-2026

In the FDA's words

Description
Alphenix INFX-8000H, interventional fluoroscopic x-ray system 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 serial numbers: D2A1672385, A2A20Z2165, B2A1692426. Distribution: Worldwide distribution - US Nationwide and the country of Dominican Republic. Affected quantity: 3 units
Hazard
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

4 products in this recall

The agency lists each product separately. Check every one you might have.

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