510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0349-2011

ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch Allyn Acuity Central...

Welch Allyn Protocol, Inc. / initiated 2009-05-01 / Terminated
FDA source (opens on fda.gov)

Welch Allyn Protocol, Inc began a recall of 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... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0349-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Welch Allyn Protocol, Inc.
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
Product code
DSI Detector And Alarm, Arrhythmia
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 root 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.
Product codes and lots
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.