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 |
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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