Recall Z-0190-2022 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
FujiFilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
| Date | Oct 14, 2021 |
| Status | Open, Classified |
| Reason | Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual. |
| Root cause | Software design |
| Action | Fujifi Film issued Medical Device Correction Notice letter dated 10/07/21 via courier on 10/14/21. Letter states reason for recall, health risk and action to take: Customers/Users are advised to accept the corrected software and manual as soon as available. Advisory Notification applies to all customers and distributors of the ARIETTA 850 systems with software version V1.0.0 through V4.1.3, See following page for complete list of affected systems. We will contact you to set up time to update the software and provide the revised manual. (7) Other Information: For questions, comments, or concer |
| Quantity | 38 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |