Events

Rappel de Device Recall PHILIPS Xper Flex Cardio Physiomonitoring System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invivo Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79611
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1867-2018
  • Date de mise en oeuvre de l'événement
    2018-03-14
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162767
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    The real-time numeric value for ventricular end-diastolic pressure (edp) displayed on the live display may be inaccurate. because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the fc2010 device, the fc2020 device, which is used in the pre or post-op holding areas, is not impacted by this issue.
  • Action
    The firm initiated their recall by letter on March 14, 2018. The Field Safety Notice informed the consignee about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer / user in order to prevent risks for patients " the actions planned by Philips to correct the problem. If further information or support concerning this problem is needed, the consignee was directed contact the local Philips representative: 800-669-1328 option 2, then option 3.

Device

Device Recall PHILIPS Xper Flex Cardio Physiomonitoring System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Italy, Kazakhstan, Kenya, Malaysia, Mexico, Mauritius, Netherlands, New Zealand, Pakistan, Philippines, Poland, Romania, Russian Fed, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Utd. Arab Emir, Uzbekistan and Vietnam.
  • Description du dispositif
    PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) || The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Adresse du fabricant
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA