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    NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·April 10, 2008

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    Allura Xper FD10/10 x-ray system

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·February 6, 2006

    FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·December 14, 2006

    Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code KPR·January 21, 2009

    EasyDiagnost Eleva x-ray systems

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·December 10, 2008

    Integris XPER FD10 F/C

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·December 10, 2008

    Allura XPER 10/10

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·December 10, 2008

    MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane. The Monoplane system has one C-arm and it could be mounted on a ceiling or on the floor stand. The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·February 4, 2010

    Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code LNH·September 19, 2008

    Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code LNH·September 19, 2008

    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code DSI·November 21, 2008

    BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·February 4, 2010

    Allura Xper FD 20/10 x-ray, and fluoroscopy

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·October 12, 2006

    Philips Easy Diagnost Eleva

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code KPR·July 23, 2007

    General X-Ray System types with Digital Spot Imaging (DSI) software

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZJ·May 23, 2008

    Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·October 7, 2010

    The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. It has a System Part Number: 989605392501, 989605396032, 989605395201. Tool Connection Unit Part Number: 453561426002, 453561443201 The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAK·June 1, 2011

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code MKJ·July 26, 2012