Health product recall

INFINIX VC-I-SYSTEM & ALPHENIX INFX-8000C - MAIN UNIT (2020-09-11)

Starting date:
September 11, 2020
Posting date:
September 25, 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-74007

Last updated:
2020-09-25

Affected Products

  1. INFINIX VC-I-SYSTEM
  2. ALPHENIX INFX-8000C - MAIN UNIT

Reason

X-ray fluoroscopy may be inhibited due to a system error caused by a broken flat panel detector (FPD) power cable.

Affected products

A. INFINIX VC-I-SYSTEM

Lot or serial number
  • SN KEB1852001
  • SN KEB1852002
  • SN KFA17X7001
  • SN KFB1892001
Model or catalog number
  • INFX-8000C/KF
  • INFX-8000H/KE
Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN

B. ALPHENIX INFX-8000C - MAIN UNIT

Lot or serial number

Not applicable.

Model or catalog number

INFX-8000C

Companies
Manufacturer

Canon Medical Systems Corporation

1385 Shimoishigami

Otawara-shi, Tochigi

324-8550

JAPAN