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Open, Classified

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

FDA Recall Z-0192-2022 · Posted None

Recalling FirmFujiFilm Healthcare Americas Corporation
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2021-10-14
Product Quantity48 US

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

Firm Action

Fujifilm issued Urgent Medical Device Correction letter dated 10/7/21, mailed 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. The Advisory Notification applies to all customers and distributors of the ARIETTA 65 system with software version V1.0 through V4.0.0. We will contact you to set up time to update the software and provide the revised manual. For questions, comments, or concerns, please contact: Aaron Pierce, Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749. Email [email protected]

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181376ARIETTA 65Hitachi Healthcare Americas Corporation · 2018-07-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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