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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm

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  Class 2 Device Recall Fujifilm see related information
Date Initiated by Firm October 14, 2021
Create Date November 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-0192-2022
Recall Event ID 88849
510(K)Number K181376  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Arietta 65 Ultrasound
Software Versions: V1.0 through V4.0.0
Code Information Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11)200929(21)G3082956 G3085640 (01)04562122959278(11)200929(21)G3085640 G3085644 (01)04562122959278(11)200929(21)G3085644 G3095193 (01)04562122959278(11)201211(21)G3095193 G3095194 (01)04562122959278(11)201211(21)G3095194 G3095195 (01)04562122959278(11)201211(21)G3095195 G3095197 (01)04562122959278(11)201211(21)G3095197 G3095202 (01)04562122959278(11)201211(21)G3095202 G3095445 (01)04562122959278(11)201228(21)G3095445 G3111596 (01)04562122959278(11)210401(21)G3111596 G3111597 (01)04562122959278(11)210401(21)G3111597 G3111598 (01)04562122959278(11)210401(21)G3111598 G3111605 (01)04562122959278(11)210402(21)G3111605 G3111606 (01)04562122959278(11)210402(21)G3111606 G3114264 (01)04562122959278(11)210428(21)G3114264 G3114267 (01)04562122959278(11)210428(21)G3114267 G3114366 (01)04562122959278(11)210514(21)G3114366 G3114368 (01)04562122959278(11)210514(21)G3114368 G3114372 (01)04562122959278(11)210517(21)G3114372 G3114373 (01)04562122959278(11)210517(21)G3114373 G3114376 (01)04562122959278(11)210517(21)G3114376 G3114379 (01)04562122959278(11)210517(21)G3114379 G3114399 (01)04562122959278(11)210518(21)G3114399 G3114897 (01)04562122959278(11)210519(21)G3114897 G3114902 (01)04562122959278(11)210519(21)G3114902 G3118967 (01)04562122959278(11)210528(21)G3118967 G3118968 (01)04562122959278(11)210528(21)G3118968
Recalling Firm/
Manufacturer		 FujiFilm Healthcare Americas Corporation
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Aaron Pierce
330-425-1313 Ext. 3720
Manufacturer 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
FDA Determined
Cause 2		 Software design
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 aaron.pierce@fujifilm.com
Quantity in Commerce 48 US
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas Corporation
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