Events

Retiro De Equipo (Recall) de Device Recall Philips IntelliVue Information Center

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 Philips Medical Systems North America Co. Phillips.

¿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
    50215
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0034-2011
  • Fecha de inicio del evento
    2008-11-21
  • Fecha de publicación del evento
    2010-10-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74994
  • 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
    Arrhythmia Detector and Alarm - Product Code DSI
  • Causa
    Potential for internal sound amplifier to malfunction which could delay treatment.
  • Acción
    On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.

Device

Device Recall Philips IntelliVue Information Center
  • Modelo / Serial
    Serial numbers are:  4810A03287, 4810A03260, 4810A03261, 4810A03262, 4810A04902, 4810A04906, 4810A04907, 4810A04908, 4810A04909, 4810A04910, 4810A04911, 4810A04912, 4810A05422, 4810A05423, 4810A11902, 4810A03367, 4810A03368, 4810A03369, 4810A03370, 4810A03372, 4810A03231, 4810A03240, 4810A03241, 4810A03242, 4810A03254, 4810A03255, 4810A03256, 4810A03257, 4810A03243, 4810A03244, 4810A03245, 4810A02772, 4810A04096, 4810A04097, 4810A04094, 4810A04095, 4810A04084, 4810A04085, 4810A03710, 4810A03711, 4810A03407, 4810A03408, 4810A03409, 4810A03410, 4810A04494, 4810A03934, 4810A03935, 4810A04768, 4810A04783, 4810A04809, 4810A04810, 4810A03631, 4810A04805, 4810A04598, 4810A11904, 4810A04053, 4810A11873, 4810A05158, 4810A05167, 4810A03078, 4810A03762, 4810A11903, 4810A05378, 4810A04798, 4810A04799, 4810A04800, 4810A04764, 4810A04765, 4810A04801, 4810A04802, 4810A04803, 4810A04804, 4810A04784, 4810A04785, 4810A04786, 4820A10136, 4820A10138, 4820A10139, 4820A10124, 4820A10125, 4820A11906, 4820A11905, 4810A03623, 4810A04796, 4810A04763, 4810A04777, 4810A04778, 4810A04779, 4810A04780, 4810A04781, 4810A09398, 4810A11851, 4810A03643, 4810A04664, 4810A04650, 4810A04651, 4810A04652, 4810A09748, 4810A09749, 4810A04565, 4810A04567, 4810A04568, 4810A05277, 4810A05278, 4810A05280, 4810A05281, 4810A04437, 4810A04438, 4810A05288, 4810A05289, 4810A05290, 4810A05291, 4810A05292, 4810A05293, 4810A05282, 4810A05283, 4810A05284, 4810A05285, 4810A05286, 4810A05287, 4810A04573, 4810A04574, 4810A04663, 4810A02713, 4810A02714, 4810A02715, 4810A02716, 4810A02762, 4810A02770, 4810A05397, 4810A05398, 4810A05399, 4810A05400, 4810A11881, 4810A05424, 4810A09648, 4810A09649, 4810A09650, 4810A09651, 4810A03699, 4810A03700, 4810A03702, 4810A03703, 4810A02941, 4810A02942, 4810A02943, 4810A02944, 4810A02945, 4810A02946, 4810A02947, 4810A02948, 4810A09687, 4810A11858, 4810A11877, 4810A02976, 4810A02962, 4810A02963, 4810A02964, 4810A02965, 4810A02966, 4810A02922, 4810A05425, 4810A05413, 4810A05417, 4810A04557, 4810A04555, 4810A04556, 4810A04504, 4810A04505, 4810A04506, 4810A04507, 4810A04508, 4810A04509, 4810A04510, 4810A04511, 4825A06062, 4825A06065, 4825A06063, 4825A06064, 4810A09047, 4810A09048, 4810A09049, 4810A09050, 4810A09051, 4810A09052, 4810A09053, 4810A09054, 4810A09055, 4810A09056, 4810A09084, 4810A09085, 4810A09086, 4810A09087, 4810A09302, 4815A05570, 4815A05571, 4815A05574, 4815A05573, 4810A05247, 4810A09756, 4810A11893, 4810A11894, 4810A10015, 4810A10016, 4810A10018, 4810A10019, 4810A10020, 4810A10021, 4810A02915, 4810A02874, 4825A06101, 4825A06102, 4825A06116, 4825A06117, 4810A09436, 4810A10078, 4810A10079, 4810A10083, 4810A09634, 4810A09635, 4810A09654, 4810A09655, 4810A09656, 4810A09657, 4810A09640, 4810A09645, 4810A09658, 4810A09641, 4810A09642, 4810A09659, 4810A09660, 4810A09661, 4810A09662, 4810A09463, 4810A09425, 4810A09462, 4810A09464, 4810A09892, 4810A09894, 4810A09876, 4810A09877, 4810A09878, 4810A09879, 4810A09880, 4810A09881, 4810A09895, 4810A09893, 4810A09882, 4810A09883, 4810A09884, 4810A05147, 4810A04228, 4810A04292, 4810A04293, 4810A04294, 4815A05914, 4815A05915, 4815A05882, 4815A05883, 4815A05884, 4815A05901, 4815A05902, 4815A05903, 4815A05904, 4815A05905, 4815A05906, 4810A02786, 4810A02787, 4810A02788, 4825A06053, 4825A06049, 4825A06050, 4825A06051, 4825A06052, 4825A06044, 4825A06045, 4825A06046, 4825A06047, 4825A06048, 4825A06092, 4825A06038, 4825A06039, 4825A06040, 4825A06041, 4825A06042, 4825A06043, 4825A06056, 4810A04970, 4810A04971, 4810A04974, 4810A04975, 4810A04976, 4810A04977, 4810A04978, 4810A04979, 4810A05030, 4810A05031, 4810A03323, 4810A03324, 4810A03325, 4810A09359, 4810A09360, 4810A05083, 4810A04544, 4810A04545, 4810A04546, 4810A04547, 4810A04548, 4810A04550, 4810A04551, 4810A04552, 4810A04553, 4810A09215, 4810A09199, 4810A09200, 4810A09201, 4810A09202, 4810A09203, 4810A09212, 4810A04558, 4810A04559, 4810A04560, 4810A04561, 4810A04562, 4810A04563, 4810A04564, 4810A04048, 4810A04049, 4810A04050, 4810A04051, 4810A11857, 4810A10087, 4810A10088, 4810A10089, 4810A10090, 4810A10091, 4810A10092, 4810A10093, 4810A10094, 4815A05948, 4815A05949, 4815A05950, 4815A05951, 4815A05895, 4815A05896, 4815A05897, 4815A05898, 4810A04812, 4810A04813, 4810A03652, 4810A03653, 4810A03839, 4810A11896, 4810A11897, 4810A03575, 4810A03576, 4810A03577, 4810A03578, 4810A03581, 4810A03582, 4810A03583, 4810A03584, 4810A05406, 4810A05407, 4810A09574, 4810A09575, 4810A09576, 4810A09577, 4810A09578, 4810A09579, 4810A04662, 4810A04673, 4810A04674, 4810A03206, 4810A04303, 4810A04304, 4810A04305, 4810A04306, 4810A04386, 4810A05459, 4810A05460, 4810A05461, 4810A05504, 4815A05813, 4815A05814, 4815A05818, 4810A04124, 4810A04125, 4810A04126, 4810A04127, 4810A04128, 4810A04129, 4810A04352, 4810A04353, 4810A04354, 4810A04355, 4815A05604, 4815A05617, 4815A05618, 4815A05619, 4815A05634, 4810A04980, 4810A04998, 4810A04999, 4810A05000, 4810A05001, 4810A05002, 4810A03229, 4810A03205, 4810A03249, 4810A03204, 4810A03230, 4810A03250, 4810A05024, 4810A04981, 4810A04982, 4810A04983, 4810A04984, 4810A05025, 4810A05026, 4810A05027, 4810A05028, 4810A05009, and 4810A05012.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". || The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. || Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Dirección del fabricante
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA