BEUDAMED
    44 results · 7ms · Sources: EU EUDAMED, US FDA

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    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

    Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 29, 2025

    Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·Future Diagnostics Solutions B.V.·February 1, 2023

    Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    Veradius Unity, Model #718132

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 23, 2022

    Zenition 70, Model #718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 23, 2022

    Zenition 50, Model #718096

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 23, 2022

    V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Ongoing·Vital Scientific N.V.·October 2, 2019

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025

    Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 23, 2019

    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024

    System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 25, 2024

    Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495

    FDA Enforcement
    Class II ·Ongoing·Kreatech Biotechnology Bv·December 4, 2024