This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Infinix Systems
- Starting date:
- October 25, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15887
Recalled Products
- Infinix CF-1/BP-System
- Infinix CF-I/SP-System
- Infinix VF-I/SP-System
- Infinix VF-I/BP-System
- Infinix VC-I-System
- Infinix CC-I-System
Reason
In certain combinations of Infinix Systems, there was relabelling of a patient's image, improper patient display in the exam room and radiation exposure without the images being recorded.
Affected products
A. Infinix CF-1/BP-System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000V_/MD
Companies
- Manufacturer
- Toshiba Medical Systems Corp.
B. Infinix CF-I/SP-System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000V_/M4, INFX-8000V_/M5
Companies
- Manufacturer
- Toshiba Medical Systems Corp.
C. Infinix VF-I/SP-System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000V_/ML
Companies
- Manufacturer
- Toshiba Medical Systems Corp.
D. Infinix VF-I/BP-System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000V_/MF
Companies
- Manufacturer
- Toshiba Medical Systems Corp.
E. Infinix VC-I-System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000C_/MC
Companies
- Manufacturer
- Toshiba Medical Systems Corp.
F. Système Infinix CC-I
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INFX-8000C_/M5
Companies
- Manufacturer
- Toshiba Medical Systems Corp.