BEUDAMED
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    ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·March 20, 2013

    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·February 18, 2015

    AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter in order to monitor the hydrostatic pressure in the bladder.

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·August 22, 2018

    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·July 25, 2018

    Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·November 1, 2017

    VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.

    FDA Enforcement
    Class II ·Terminated·Nucletron BV·January 8, 2020

    VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    FDA Enforcement
    Class II ·Terminated·Vitreq Bv·February 5, 2020