Events

Device Recall 19 ViewSonic LCD VG930M Display 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Welch Allyn Protocol, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    51883
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0349-2011
  • 사례 시작날짜
    2009-05-01
  • 사례 출판 날짜
    2010-11-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81539
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Detector and alarm, arrhythmia - Product Code DSI
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 제조사 주소
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA