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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 48
Distribution
Distributed nationwide across the United States.
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