FDA Device Recall Z-0192-2022: FujiFilm Healthcare Americas Corporation

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0192-2022.

Recall Res Number

Z-0192-2022

Recalling Firm / Manufacturer

FujiFilm Healthcare Americas Corporation

FEI Number

1528028

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2021-10-14

Date Posted

N/A

Date Terminated

N/A

Product Code

IYN

Event Number

88849

Product Quantity

48 US

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

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

Action Details 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

Distribution Pattern US Nationwide distribution.

Code Information / Serial Numbers 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

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VERMON Registration: 1000269286 View Registration
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OLDELFT B.V. Registration: 1000601180 View Registration
ASUS Registration: 1000602763 View Registration
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Philips Ultrasound LLC Registration: 2518586 View Registration
PENTAX of America, Inc. Registration: 2518897 View Registration
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PARALLEL DESIGN SAS Registration: 3003594449 View Registration
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PROBO MEDICAL SAS Registration: 3035950510 View Registration
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YORLABS, INC. Registration: 3038718997 View Registration
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ESAOTE S.P.A. Registration: 9611125 View Registration
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Medical Device Recall: Z-0192-2022

Recall Parameters & Description

Related Establishments / Registrations

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