BEUDAMED
    234 results · 12ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    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

    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

    C9-3v Transducer Probe

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

    C10-3v Transducer Probe

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

    D5cwc Transducer Probe

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

    C8-4v Transducer Probe

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

    BP10-5ec Transducer Probe

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

    C9-5ec Transducer Probe

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

    C9-3io Transducer Probe

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

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 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

    bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

    FDA Recall
    Open, Classified ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023

    GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

    FDA Recall
    Open, Classified ·GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway·Product code IYN·May 2, 2024

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

    FDA Recall
    Open, Classified ·FujiFilm Healthcare Americas Corporation·Product code IYN·October 14, 2021

    S4-1 Lumify Transducer Probe

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