FDA recall, , Moderate risk
Canon Alphenix Interventional Fluoroscopic X-Ray Systems
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.
Summary by Recall Canary from the FDA notice
What happened
FDA, 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.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Compare these details with yours, then check the recall notice to see which units are recalled.
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Dominican Republic.
- Company
- Canon Medical System, USA, INC.Tustin, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97970
- Recall numbers
- Z-1176-2026 to Z-1179-2026
All recalls from Canon Medical System, USA, INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary