BEUDAMED
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    OEC 3D

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OXO·March 21, 2025

    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OXO·March 21, 2025

    Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code MBI·August 23, 2023

    Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code KDD·September 13, 2023

    Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·March 10, 2025

    Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·June 20, 2018

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 9, 2023

    Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 9, 2023

    Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JNL·September 5, 2024

    Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system

    FDA Recall
    Open, Classified ·Medtronic Neuromodulation·Product code LGW·September 18, 2024

    Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11, 15-2835/12, 15-2836/11, 15-2836/12, 15-2837/11, 15-2837/12, 15-2838/11, 15-2838/12, 15-3815/11, 15-3815/12, 15-3816/11, 15-3816/12, 15-3817/11, 15-3817/12, 15-3818/11, 15-3818/12, 15-8521/05, 15-8521/07, 15-8521/09, 15-8521/11, 15-8521/15, 15-8521/25, 15-8521/27, 15-8521/29, 15-8521/31, 15-8521/33

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·May 22, 2024

    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code LWS·November 30, 2023

    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

    FDA Recall
    Open, Classified ·Philips Healthcare (Suzhou) Co., Ltd. Suzhou Industrial Park No.·Product code JAK·December 23, 2022

    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NVY·September 30, 2022

    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code NVY·September 30, 2022

    Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·December 9, 2024

    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·February 10, 2023

    VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·December 9, 2024

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·January 26, 2023