Recall Z-0192-2022— FujiFilm Healthcare Americas Corporation
Class II · Ongoing
Class II FDA medical device recall by FujiFilm Healthcare Americas Corporation, initiated 2021-10-14. It names one FDA 510(k) clearance: K181376. Product: Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0. Reason: When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual.
- Recalling firm
- FujiFilm Healthcare Americas Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-14
- Firm location
- Twinsburg, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Reason for recall
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
Data sourced from openFDA. This site is unofficial and independent of the FDA.