BEUDAMED
    219 results · 42ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LLZ·July 27, 2011

    Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013

    Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 22, 2012

    Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 20, 2012

    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 18, 2012

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·September 26, 2012

    Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 4, 2012

    Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·February 6, 2013

    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 15, 2012

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·August 22, 2012

    Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·May 8, 2013

    Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·June 26, 2013

    Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·September 4, 2013

    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·February 20, 2013