BEUDAMED
    179 results · 48ms · 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 FDA Recall ×

    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 Avalon Fetal Monitor FM30; Model Number: M2703A.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code HGM·May 12, 2009

    HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MKJ·March 30, 2009

    IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DXJ·October 21, 2009

    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MKJ·January 28, 2013

    HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MKJ·May 6, 2010

    Philips Intellivue Patient Monitor Model MP70 (M8007A)

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code MHX·June 28, 2010

    Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 and CO2 tension at the skin surface for neonates and adults as an adjunct to arterial O2 and CO2 measurements.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LKD·November 19, 2009

    Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code BZC·November 19, 2009

    Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·November 19, 2009

    REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code BZC·November 19, 2009

    100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive monitoring of functional saturation (SpO2) and pulse rate.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code DQA·November 19, 2009

    Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This by performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code CCK·April 7, 2011

    Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IZI·April 2, 2012