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Health Canada Medical devices

ALOKA ARIETTA 850

Issued November 19, 2021
Issue
Two issues with the diagnostic ultrasound system Arietta 850 (software version V1.0.0 - V4.1.3) Used in combination with a Fujifilm (formally Hitachi) Transducer: (1) the calculation result of eroa is displayed incorrectly when measuring lvot flow, lvot and MR flow. This error also appears in the user manual. (2) The calculation result for MVA (VTI) is displayed incorrectly when measuring MV. Recall start date: 2021-10-26
Hazard description
Inaccurate test or measurement results
Product
Product name
ALOKA ARIETTA 850
Reference
ID
RA-63615