Infinix and Alphenix Systen C-Arm Suspension and Table
Brand(s)
Last updated
Summary
Product
Infinix and Alphenix Systen C-Arm Suspension and Table
Issue
Medical devices - Performance
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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