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U.S. Department of Health and Human Services

Class 2 Device Recall Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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 Class 2 Device Recall Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3see related information
Date Initiated by FirmOctober 14, 2021
Create DateNovember 02, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0189-2022
Recall Event ID 88840
510(K)NumberK191233 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductArietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Code Information Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Recalling Firm/
Manufacturer		 FujiFilm Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information ContactAaron Pierce
330-425-1313 Ext. 3720
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionFujifi 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 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 aaron.pierce@fujifilm.com
Quantity in Commerce15 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYN
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