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