BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Unistik® Pro

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·January 11, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014

    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