Events

Rappel de Device Recall 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
    78585
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0263-2018
  • Date de mise en oeuvre de l'événement
    2017-08-18
  • 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=159835
  • 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
    Intermittent communication between the host system and the flexcardio.
  • Action
    On August 24, 2017 Philips send the following communications to distributors and clients. Dear Distributor, Philips is initiating an action related to the Xper Flex Cardio Patient Monitoring System. The attached Field Safety Notice is intended to inform customers 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, users or servicers " the actions planned by Philips to correct the problem. It is imperative that all affected end users of the Xper Flex Cardio receive the attached Field Safety Notice. Because Philips sells these products through distributors, including your organization, we may not have the information necessary to contact all end users. Therefore, please send the attached Field Safety Notice to each customer to whom you have distributed one of the affected devices. A description of the affected device can be found in the Field Safety Notice attached. -- Dear Customer, A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System (Flex Cardio) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you 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 or users " the actions planned by Philips to correct the problem. Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment: " Boom Monitor (display) may not display all active waveform and/or vital sign data. " Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor. " After patient admission and ca

Device

Device Recall Xper Flex Cardio Physiomonitoring system
  • Modèle / numéro de série
    All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Papua, Paraguay, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Yemen
  • Description du dispositif
    Xper Flex Cardio Physiomonitoring system. || Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
  • 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