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Health product recall

Aquilion ONE System - Software (2014-08-12)

Starting date:
August 12, 2014
Posting date:
September 9, 2014
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-41283

Recalled Products

Aquilion ONE System - Software 

Reason

In the Aquilion ONE system with CFA option (optional CT cardiac function analysis- hereinafter referred to as CFA), it has been found that correct analysis results may not be displayed.

Affected products

Aquilion ONE System - Software 

Lot or serial number
  • S/N: 1BA08Z2048
  • S/N: 1BA1022087
  • S/N: 1BB0852020
  • S/N: 1BC0872022
  • S/N: 1BC0882035
  • S/N:1BA0822013
  • S/N:1BC0882036
  • S/N:1BC08X2041
  • S/N:1BC09X2075
Model or catalog number

CSCF-003A

Companies
Manufacturer
Toshiba Medical Systems Corp.
1385 Shimoishigami, Otawara-Shi
Tochigi-Ken
324-8550
JAPAN

Date modified: