Health product recall

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 

  1. INFINIX CF-I/SP-SYSTEM
  2. INFINIX VF-I/SP-SYSTEM
  3. INFINIX VC-I-SYSTEM
  4. 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