BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    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

    HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

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

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; 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;

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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number U128, VALITUDE CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number L210 PROPONENT SR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025