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Alphenix infx-8000v - main unit

Official notice

8 Nov 2023

Last checked

8 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Alphenix infx-8000v - main unit. 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 Published 2023-11-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74565

Official notice

2023-11-08

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74565

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Affected products

Product 1

Affected products - Alphenix INFX-8000v - Main Unit, Lot or serial number - PVD2292001, Model or catalogue number - INFX-8000V/PV

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Canon, Alphenix Infx-8000v - Main Unit.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74565

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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