Events

Retiro De Equipo (Recall) de Device Recall Xper Flex Cardio Physiomonitoring system

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Invivo Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78585
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0263-2018
  • Fecha de inicio del evento
    2017-08-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159835
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
  • Causa
    Intermittent communication between the host system and the flexcardio.
  • Acción
    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
  • Modelo / Serial
    All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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
  • Dirección del fabricante
    Invivo Corporation, 12151 Research Pkwy Ste 200, Orlando FL 32826-3286
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA