Events

Rappel de Device Recall 19 ViewSonic LCD VG930M Display

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 Welch Allyn Protocol, Inc.

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
    51883
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0349-2011
  • Date de mise en oeuvre de l'événement
    2009-05-01
  • Date de publication de l'événement
    2010-11-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81539
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA