Events

Retiro De Equipo (Recall) de Device Recall 19 ViewSonic LCD VG930M Display

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 Welch Allyn Protocol, Inc.

¿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
    51883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0349-2011
  • Fecha de inicio del evento
    2009-05-01
  • Fecha de publicación del evento
    2010-11-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81539
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Causa
    The 19" model vg930m viewsonic flat panel lcd display may have faulty capacitors at certain locations in the power supply section. the faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.
  • Acción
    On May 1, 2009, Welch Allyn Protocol, Inc. sent out recall notification to their consignees in via UPS and US Postal Certified Mail. The letter describes the recalled product as 19" model VGM930M ViewSonic flat panel LCD display with serial numbers less than QC2082880001. For the Welch Allyn service contract consignees/customers, the firm's Field Service Engineer will replace the LCD monitor for the consignees. The consignees could contact Technical Support at 1-800-289-2501. For the Warranty/non-Warranty contract consignees/customers-For the Welch Allyn service contract consignees, Stericycle Return Management Services (RMS) will manage all recall and recovery initiatives. Consignees/customers can call Welch Allyn Customer Care at 1-800-535-6663 for any questions or concern about this recall.

Device

Device Recall 19 ViewSonic LCD VG930M Display
  • Modelo / Serial
    Monitor's Serial Numbers:  QC2064300182, QC2064300203, QC2064300215, QC2064300216, QC2064300217, QC2064300218, QC2064300219, QC2064300220, QC2064300221, QC2064300223, QC2064300224, QC2064300225, QC2064300232, QC2064300338, QC2064300442, QC2064300450, QC2064300808, QC2064300812, QC2064300817, QC2064300819, QC2064300820, QC2064300821, QC2064300822, QC2064300830, QC2064300833, QC2064300932, QC2064301159, QC2064301961, QC2064302001, QC2064302034, QC2064302036, QC2064302041, QC2064302042, QC2064302046, QC2064302047, QC2064302049, QC2064302051, QC2064302367, QC2064305127, QC2064305128, QC2064305129, QC2064305130, QC2064305135, QC2064305136, QC2064305137, QC2064305138, QC2064305139, QC2064305143, QC2064305257, QC2064305425, QC2064305455, QC2064401500, QC2064401501, QC2064401505, QC2064401662, QC2064401664, QC2064401674, QC2064402100, QC2064402130, QC2064500589, QC2064501493, QC2064502289, QC2064502304, QC2064502402, QC2064502515, QC2064502516, QC2064502517, QC2064502519, QC2064502564, QC2064502565, QC2064502566, QC2064503608, QC2064503609, QC2064503610, QC2064503613, QC2064503616, QC2064503621, QC2064701017, QC2064701020, QC2064701021, QC2064701027, QC2064701029, QC2064701035, QC2064701865, QC2064701867, QC2064701868, QC2064705525, QC2064705531, QC2064705532, QC2064705533, QC2064705534, QC2064705535, QC2064705539, QC2064705547, QC2064706184, QC2064710246, QC2064710480, QC2064710529, QC2064710534, QC2064710536, QC2064710538, QC2064710539, QC2064710543, QC2064710548, QC2064710550, QC2070100026, QC2070100036, QC2070100037, QC2070100038, QC2070100046, QC2070100047, QC2070100053, QC2070100074, QC2070100278, QC2070100329, QC2070100391, QC2070100437, QC2070100452, QC2070100453, QC2070100754, QC2070100884, QC2070100897, QC2070100898, QC2070101083, QC2070101107, QC2070101113, QC2070101115, QC2070101125, QC2070101154, QC2070101155, QC2070101168, QC2070642104, QC2070642105, QC2070642106, QC2070642107, QC2070642108, QC2070642109, QC2070642110, QC2070642111, QC2070642112, QC2070642115, QC2070642121, QC2070642122, QC2070642123, QC2070642124, QC2070642214, QC2070642215, QC2070642643, QC2070642645, QC2070642646, QC2070642647, QC2070642649, QC2070642650, QC2070642651, QC2070642656, QC2070642657, QC2070642660, QC2070642661, QC2070643089, QC2070940319, QC2070940324, QC2070940325, QC2070940326, QC2070940327, QC2070940331, QC2070940408, QC2070940410, QC2070940538, QC2071400935, QC2071401204, QC2071401205, QC2071401206, QC2071401207, QC2071401208, QC2071401209, QC2071401210, QC2071401211, QC2071401214, QC2071401215, QC2071401216, QC2071401218, QC2071401580, QC2071501615, QC2071501619, QC2071501620, QC2071501621, QC2071501624, QC2071501627, QC2071501628, QC2071501629, QC2071501631, QC2071501633, QC2071504074, QC2071504094, QC2071504099, QC2071504102, QC2071504103, QC2071504190, QC2071504230, QC2072209740, QC2072209801, QC2072209909, QC2072210154, QC2072210155, QC2072210156, QC2072210162, QC2072210163, QC2072210168, QC2072210445, QC2072210448, QC2072210451, QC2072210452, QC2072210453, QC2072210454, QC2072210455, QC2072210456, QC2072210458, QC2072210459, QC2072210460, QC2072210461, QC2072210462, QC2072210463, QC2072210464, QC2072210465, QC2072210466, QC2072210467, QC2072210468, QC2072210472, QC2072210473, QC2072210565, QC2072210566, QC2072302030, QC2072302084, QC2072302142, QC2072302165, QC2072302166, QC2072302179, QC2072302218, QC2072302242, QC2072302243, QC2072302244, QC2072302245, QC2072302246, QC2072302248, QC2072302250, QC2072302256, QC2072302257, QC2072302258, QC2072302259, QC2072302260, QC2072302261, QC2072302262, QC2072302263, QC2072302265, QC2072302266, QC2072302267, QC2072302268, QC2072302269, QC2072302270, QC2072302271, QC2072302272, QC2072302273, QC2072302274, QC2072302275, QC2072302309, QC2072302315, QC2072302372, QC2072302394, QC2072302396, QC2072302432, QC2072400023, QC2072400026, QC2072400071, QC2072400080, QC2072400178, QC2072400180, QC2072400193, QC2072400292, QC2072400299, QC2072400306, QC2072400307, QC2072400314, QC2072400315, QC2072400316, QC2072400318, QC2072400319, QC2072400328, QC2072400329, QC2072400332, QC2072400333, QC2072400339, QC2072400374, QC2072400424, QC2072400425, QC2072400431, QC2072400432, QC2072400433, QC2072400436, QC2072400442, QC2072400445, QC2072400447, QC2072400453, QC2072400455, QC2072400458, QC2072400463, QC2072400467, QC2072400479, QC2072400480, QC2072400488, QC2072400500, QC2072400501, QC2072400502, QC2072400503, QC2072400504, QC2072400506, QC2072400568, QC2072400597, QC2072400598, QC2072400599, QC2072400600, QC2072400604, QC2072400605, QC2072400606, QC2072400607, QC2072400612, QC2072400618, QC2072400999, QC2072401004, QC2072401007, QC2072401008, QC2072401011, QC2072401012, QC2072401013, QC2072401014, QC2072401015, QC2072401019, QC2072401023, QC2072401287, QC2072401298, QC2072401303, QC2072401306, QC2072401307, QC2072401308, QC2072401312, QC2072401314, QC2072401317, QC2072401318, QC2072401322, QC2072401440, QC2072401444, QC2072401454, QC2072401455, QC2072401457, QC2072401458, QC2072401459, QC2072401828, QC2072401830, QC2072401832, QC2072401835, QC2072401836, QC2072401837, QC2072401867, QC2072402075, QC2072402194, QC2072402342, QC2072402400, QC2072402404, QC2072402459, QC2072402463, QC2072402551, QC2072402553, QC2072402554, QC2072402555, QC2072402557, QC2072402560, QC2072402561, QC2072402562, QC2072402564, QC2072402565, QC2072402566, QC2072402568, QC2072402569, QC2072402570, QC2072402580, QC2072402665, QC2072402743, QC2072402744, QC2072402748, QC2072402953, QC2072402955, QC2072402956, QC2072402957, QC2072402963, QC2072402964, QC2072402972, QC2072402973, QC2072402974, QC2072402975, QC2072403018, QC2072403023, QC2072403047, QC2072403048, QC2072403049, QC2072403050, QC2072403051, QC2072403052, QC2072403053, QC2072403054, QC2072403055, QC2072403056, QC2072403057, QC2072403058, QC2072403060, QC2072403061, QC2072403062, QC2072403064, QC2072403065, QC2072403066, QC2072403067, QC2072403069, QC2072403070, QC2072403593, QC2072403616, QC2072403621, QC2072403632, QC2072403634, QC2072403653, QC2072403656, QC2072403668, QC2072403669, QC2072403684, QC2072500497, QC2072500645, QC2072500646, QC2072500647, QC2072500649, QC2072500651, QC2072500652, QC2072500653, QC2072500654, QC2072500661, QC2072500663, QC2072600015, QC2072600575, QC2072600647, QC2072600667, QC2072600703, QC2072600711, QC2072600742, QC2072600743, QC2072600744, QC2072600745, QC2072600746, QC2072600747, QC2072600748, QC2072600749, QC2072600751, QC2072600752, QC2072600753, QC2072601185, QC2072601186, QC2072601187, QC2072601190, QC2072601191, QC2072601192, QC2072601195, QC2072601197, QC2072601198, QC2072601680, QC2073604889, QC2073604890, QC2073604897, QC2073604898, QC2073604899, QC2073605371, QC2073702035, QC2073702040, QC2073702041, QC2073702043, QC2073702046, QC2073702204, QC2075000073, QC2075000462, QC2075000463, QC2075000471, QC2075000472, QC2075000473, QC2075000535, QC2075000558, QC2075000658, QC2075000662, QC2075000996, QC2075001212, QC2080260893, QC2080260941, QC2080260952, QC2080260959, QC2080260981, QC2080260983, QC2080260984, QC2080260986, QC2080260991, QC2080261300, QC2080261766, QC2080261773, QC2080262093, QC2080262098, QC2080262294, QC2080262324, QC2080262337, QC2080262349, QC2080262351, QC2080262353, QC2080262406, QC2080360295, QC2080360296, QC2080360299, QC2080360305, QC2080760001, QC2080760007, QC2080760010, QC2080760020, QC2080760021, QC2080760022, QC2080760128, QC2080760192, QC2080760211, QC2080760213, QC2080760214, QC2080760215, QC2080760216, QC2080760245, QC2080760277, QC2080760557, QC2080760705, QC2080760709, QC2080760710, QC2080760711, QC2080760728, QC2080760996, QC2080761023, QC2080761024, QC2080761064, QC2080761071, QC2080761074, QC2080761076, QC2080761087, QC2081260196, QC2081260238, QC2081260241, QC2081260245, QC2081260249, QC2081260530, QC2081260594, QC2081561274, QC2081561276, QC2081561279, QC2081561280, QC2081561281, QC2081561290, QC2081561310, QC2081561311, QC2081561312, QC2081561313, QC2081561315, QC2081561316, QC2081561317, QC2081561318, QC2081561319, QC2081561320, QC2081561321, QC2081561322, QC2081561323, QC2081561324, QC2081561328, QC2081561329, QC2081561330, QC2081561331, QC2081561419, QC2081561420, QC2081760346, QC2081760373, QC2081760374, QC2081760376, QC2081760380, QC2081760381, QC2081760382, QC2081760384, QC2081760387, QC2081760391, QC2081760462, QC2081760467, QC2081760504, QC2081760590, QC2081761421, QC2081761422, QC2081761424, QC2081761425, QC2081761426, QC2081761427, QC2081761428, QC2081761429, QC2081761430, QC2081761432, QC2081761435, QC2081761436, QC2081761438, QC2081761439, QC2081761440, QC2081761441, QC2081761442, QC2081761454, QC2081761455, QC2081761466, QC2081762307, QC2081762384, QC2082384491, QC2082384639, QC2082384640, QC2082384641, QC2082384642, QC2082384643, QC2082384644, QC2082384645, QC2082384646, QC2082384647, QC2082384648, QC2082384653, QC2082384654, QC2082384655, QC2082384656, QC2082384658, QC2082384659, QC2082384660, QC2082384662, QC2082384891,  and QC2082384929.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: AK, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VT, WI, and WV; and countries including: AUSTRALIA, CANADA, ESTONIA, GERMANY, ICELAND, IRELAND, ITALY, JORDAN, MALAYSIA, POLAND, and RUSSIA.
  • Descripción del producto
    ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central Monitoring System. The affected serial numbers are those less than QC2082880001. || The ViewSonic 19" flat panel LCD display Model VG930M is used as part of the Welch Allyn Acuity Central Monitoring System (Acuity System.) The Acuity System consists of a central monitoring station, Acuity System software, and a collection of other commercially available networked products
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Dirección del fabricante
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA