Events

Retiro De Equipo (Recall) de Invivo Corporation Expression MRI Patient Monitoring 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
    63643
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0468-2013
  • Fecha de inicio del evento
    2012-10-15
  • Fecha de publicación del evento
    2012-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114405
  • 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
    Invivo corporation located at 12151 research parkway, orlando, fl 32826 is recalling the expression mri patient monitoring system because during transport of the systems cart with a docked display controller unit (dcu), a caster (wheel) may become detached. if this occurs, the cart can become unbalanced and may fall.
  • Acción
    Philips Healthcare sent an "URGENT-MEDICAL DEVICE RECALL" letter dated October 15, 2012 to all affected customers. The letter identified the product, problem, and actons to be taken by the customers. Customers were instructed to inspect all casters of the unit to ensure that they are all secured. If a caster is loose, customers were told to lock the caster in place, limit movement of the cart and contact their local Phillips Invivo Representative. Nevertheless, a Philips Invivo representative will contact the customer regarding their affected device. All affected devices will have new casters installed in order to correct the problem. Contact your local Philips Invivo Representative at 1-800-722-9377 for further information and support.

Device

Invivo Corporation Expression MRI Patient Monitoring System
  • Modelo / Serial
    Model number 865214: (Service Numbers 453564180091, 453564181201). Lot numbers: US00201487, US00201488, US00201489, US00201490, US00201493, US11401510, US11401511, US11401513, US11401514, US11401515, US11401516, US11401531, US11401532, US11401533, US11401546, US11401562, US11401563, US11401564, US11401565, US11401566, US11401567, US11401568, US11401569, US11401570, US11401571, US11401572, US11401573, US11401574, US11401575, US11401576, US11401577, US11401578, US11401579, US11401611, US11401617, US11401618, US11401631, US11401633, US11401634, US11401645, US11401646, US11401647, US11401648, US11401649, US11401651, US11401652, US11401672, US11401673, US11401674, US11401675, US11401712, US11401713, US11401714, US11401715, US11401716, US11401717, US11401718, US11401719, US11401720, US11401721, US11401722, US11401723, US11401724, US11401737, US11401738, US11401739, US11401740, US11401741, US11401742, US11401743, US11401744, US11401745, US11401746, US11401747, US11401775, US11401776, 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US13302141, US13302148, US13302175, US13302176, US13302177, US13302178, US13302179, US13302180, US13302182, US13302192, US13302193, US13302194, US13302195, US13302196, US13302197, US13302198, US13302209, US13302210, US13302211, US13302212, US13302247, US13302248, US13302249, US13302250, US13302251, US13302252, US13302254, US13302265, US13302266, US13302267, US13302291, US13302292, US13302293, US13302294, US13302295, US13302296, US13302297, US13302298, US13302300, US13302302, US13302304, US13302346, US13302347, US13302348, US13302349, US13302350, US13302362, US13302363, US13302364, US13302365, US13302366, US13302367, US13302373, US13302378, US13302421, US13302422, US13302423, US13302424, US13302425, US13302427, US13302430, US13302431, US13302432, US13302434, US13302437, US13302438, US13302439, US13302441, US13302445, US13302446, US13302447, US13302449, US13302450, US13302478, US13302485, US13302488, US13302498, US13302501, US13302503, US13302504, US13302505, US13302507, US13302508, 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.
  • Descripción del producto
    Invivo Corporation Expression MRI Patient Monitoring System. || The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Dirección del fabricante
    Invivo Corporation, 12151 Research Pkwy, Suite 200, Orlando FL 32826-3222
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA