The Recall Desk
HighFDA (Devices)·Z-0192-2022·Announced 2021-11-10

Arietta 65 Ultrasound Software: Calculation Error in EROA Diagnostic Measurements

Arietta 65 Ultrasound systems with software versions 1.0 through 4.0.0 contain a calculation error that produces incorrect measurements of cardiac valve function during diagnostic assessments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a calculation error that produces incorrect diagnostic measurements for cardiac assessments. No injuries or illnesses have been reported in the source material. The hazard represents a risk-of-harm product where injury has not yet been reported, consistent with a High severity classification.

Plain-English summary

FujiFilm Healthcare Americas Corporation is recalling Arietta 65 Ultrasound systems running software versions 1.0 through 4.0.0. The recall applies to 48 systems distributed nationwide in the United States.

When the ultrasound system is used with a Fujifilm transducer to perform cardiac flow assessment (MR Flow combined with Left Ventricular Outflow Tract Flow), a calculation error in the EROA (Effective Regurgitant Orifice Area) formula produces incorrect measurements. The error also appears in the device instruction manual.

Users of the affected Arietta 65 Ultrasound systems should contact FujiFilm Healthcare Americas Corporation regarding this issue.

The recalled product

Product
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Manufacturer
FujiFilm Healthcare Americas Corporation
Category
Medical Device — Diagnostic Ultrasound Equipment
Hazard
  • measurement-error
  • diagnostic-inaccuracy

Distribution

Distributed nationwide across the United States.

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