Class 2 Device Recall 19 ViewSonic LCD VG930M Display

• Date Initiated by Firm: May 01, 2009
• Date Posted: November 12, 2010
• Recall Status: Terminated on July 25, 2011
• Recall Number: Z-0349-2011
• Recall Event ID: 51883
• 510(K)Number: K052160
• Product Classification: Detector and alarm, arrhythmia - Product Code DSI
• Product: 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: Welch Allyn Protocol, Inc; 8500 Sw Creekside Pl; Beaverton OR 97008
• For Additional Information Contact: Richard Wynkoop; 503-530-7935
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 637 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DSI and Original Applicant = WELCH ALLYN, INC.