Health product recall

Infinix and Alphenix Systen C-Arm Suspension and Table

Last updated

Summary

Product
Infinix and Alphenix Systen C-Arm Suspension and Table
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

Infinix Vf-I/Bp-System

Not applicable.

INFX-8000V_/MF

Infinix Cc-I-System

Not applicable.

INFX-8000C_/M5
INFX-8000H/K5

Infinix Vf-I/Sp-System

Not applicable.

INFX-8000V/K3
INFX-8000V_/M7
INFX-8000V_/ML

Alphenix Infx-8000v-Main Unit

Not applicable.

INFX-8000V/PU
INFX-8000V/PV
INFX-8000V/P5
INFX-8000V/PW

C-Arm Support

Not applicable.

CAS-830A

Infinix Cf-1/Bp-System

Not applicable.

INFX-8000V_/MD

Infinix Cf-I/Sp-System

Not applicable.

INFX-8000V_/M4
INFX-8000V/K2
INFX-8000V_/M5

Infinix Vc-I-System

Not applicable.

INFX-8000H/KE
INFX-8000H/K5
INFX-8000C_/MT
INFX-8000C_/ME
INFX-8000C/KF
INFX-8000C/K6
INFX-8000C_/MF

Alphenix Infx-8000c-Main Unit

Not applicable.

INFX-8000C/PF
INFX-8000C/QU

Issue

It has been discovered that the affixing screws of the C-arm motor drive and table, that are part of the x-ray interventional system, may become loose. As a result, abnormal noises may be generated from the C-arm suspension and/or the table. Also, sensor errors may be displayed. However, please note that the affixing parts will not fall nor fail.

Recall start date: June 7, 2024

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-75720

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