CAT-880B Catheterization (2020-12-14)
- Starting date:
- December 14, 2020
- Posting date:
- December 31, 2020
- 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-74681
Last updated:
2020-12-31
Affected Products
- INFINIX CF-I/SP-SYSTEM
- INFINIX VF-I/SP-SYSTEM
- INFINIX VC-I-SYSTEM
- ALPHENIX INFX-8000C - MAIN UNIT
Reason
The CAT-880B Catheterization table top tilted because the tightening bolts that fasten the vertical column and table top tilting drive unit were loose.
Affected products
A. INFINIX CF-I/SP-SYSTEM
Lot or serial number
- K2A1777001
- K2C1922001
Model or catalog number
- INFX-8000V/K1
- INFX-8000V/K2
- INFX-8000V_/M3
- INFX-8000V_/M4
- INFX-8000V_/M5
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN
B. INFINIX VF-I/SP-SYSTEM
Lot or serial number
- M7F1442001
- MLD1417003
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN
C. INFINIX VC-I-SYSTEM
Lot or serial number
- K6B15Y7001
- KFA17X7001
- KFB1892001
- MEC1472001
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN
D. ALPHENIX INFX-8000C - MAIN UNIT
Lot or serial number
- PFA2032001
Model or catalog number
- INFX-8000C/P1
- INFX-8000C/P2
- INFX-8000C/P3
- INFX-8000C/P4
- INFX-8000C/P5
- INFX-8000C/P6
- INFX-8000C/PE
- INFX-8000C/PF
- INFX-8000C/PH
Companies
- Manufacturer
-
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi
324-8550
JAPAN