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Aloka arietta 850
Official notice
19 Nov 2021
Last checked
19 Nov 2021
An official Health Canada notice concerns Aloka arietta 850. 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 Published 2021-11-19.
What to do now
Contact the manufacturer if you require additional information
Recall number
63615
Official notice
2021-11-19
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Aloka Arietta 850.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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