BEUDAMED
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    Aplio 80; SSA-770A; software version 5.5r002

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·November 12, 2007

    Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·April 2, 2014

    ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007

    The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.

    FDA Recall
    Terminated ·Sonosite, Inc.·Product code IYN·August 13, 2010

    ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 21, 2008

    Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·January 6, 2010

    Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 1, 2010

    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·October 7, 2015

    Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code IYN·December 9, 2015

    Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code IYN·April 11, 2024

    Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

    FDA Recall
    Open, Classified ·Echonous Inc·Product code IYN·May 9, 2024

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.

    FDA Recall
    Terminated ·Butterfly Network, Inc.·Product code IYN·February 24, 2020

    Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.

    FDA Recall
    Terminated ·Philips Ultrasound Inc·Product code IYN·December 24, 2020

    Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

    FDA Recall
    Open, Classified ·NovaSignal Corp.·Product code IYN·December 16, 2022

    Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,

    FDA Recall
    Open, Classified ·Philips Ultrasound, LLC·Product code IYN·October 31, 2025

    D2TCD Transducer Probe

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code IYN·July 3, 2025

    OMNI III TEE Transducer Probe

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code IYN·July 3, 2025