Health product recall

INFINIX and INFX-8000C (2021-01-22)

Starting date:
January 22, 2021
Posting date:
February 5, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74913

Last updated:
2021-02-05

Affected Products 

A. INFINIX VF-I/SP-SYSTEM
B. INFINIX VF-I/BP-SYSTEM
C. INFINIX VC-I-SYSTEM
D. ALPHENIX INFX-8000C - MAIN UNIT

Reason

It has been found that the radiated X-ray field may shift with respect to the image receiving surface displayed on the screen at some C-arm angles. In this case, a part of the Collimator device may appear on the screen display, or X-rays may be emitted outside the display boundary.

Affected products

A. INFINIX VF-I/SP-SYSTEM

Lot or serial number

All lots. 

Model or catalog number

INFX-8000V_/M7
INFX-8000V_/ML

Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN

B. INFINIX VF-I/BP-SYSTEM

Lot or serial number

All lots. 

Model or catalog number

INFX-8000V_/MF

Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN

C. INFINIX VC-I-SYSTEM

Lot or serial number

All lots. 

Model or catalog number

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

Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN

D. ALPHENIX INFX-8000C - MAIN UNIT

Lot or serial number

All lots. 

Model or catalog number

INFX-8000C/PF

Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN