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    Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

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

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

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

    Allura Xper FD20 OR Table; Model Number: 722023;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD20; Model Number: 722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD20/10; Model Number: 722029;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD20/20; Model Number: 722038;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10F; Model Number: 722002;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10/10; Model Number: 722005;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10/10; Model Number: 722011;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10/10; Model Number: 722027;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD20 Biplane; Model Number: 722008;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD20 Biplane; Model Number: 722013;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Product Name: Allura Xper FD10C; Model number: 722001;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10; Model Number: 722010;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    V-Twin, Catalog # 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 ·Terminated·Vital Scientific N.V.·October 16, 2019

    Allura Xper FD20; Model Number: 722012;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10; Model Number: 722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Allura Xper FD10; Model Number: 722003;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Veradius Unity, Model #718132

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