Health product recall

Alphenix INFX-8000v - Main Unit

Last updated

Summary

Product
Alphenix INFX-8000v - Main Unit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Alphenix INFX-8000v - Main Unit

PVD2292001

INFX-8000V/PV

Issue

It has been found that due to problems with the internal board of x-ray flat panel detector configured in the x-ray interventional systems, abnormal images such as horizontal stripes may be displayed and recovery probably could not be possible by restarting the system.

Recall start date: October 23, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Canon Medical Systems Corporation
1385, Shimoishigami, Otawara-Shi, Tochigi-Ken, Japan, 324-8550
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74565

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