Welch Allyn PIC 50 Portable Intensive Care System 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
    56804
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0937-2011
  • 사례 시작날짜
    2010-09-17
  • 사례 출판 날짜
    2011-01-24
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-07-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    External Transcutaneous Cardiac Pacemaker (Non-Invasive) - Product Code DRO
  • 원인
    Potential likelihood that the portable intensive care (pic) 50 defibrillator's screen display may fail. the loss of the ability to view the patient's electrocardiogram (ecg) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
  • 조치
    On 9/17/10, Welch Allyn began sending out the Important Product Alert letter to all their direct consignees. On 9/24/2010, the firm sent out the letters to their distributors. The Product Alert letter informs the consignees of a low potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The consignees are advised to follow the instruction in the PIC 50 user's manual requiring routine shift equipment checks daily or at each shift change to minimize the likelihood of the malfunction from occurring. The checks ensure that the PIC 50 and its component (including the screen display) are fully operation and undamaged. The letter further states "our analysis indicates that routinely doing such checks will likely lead to discovery of this malfunction as it occurs, and thus timely maintenance and repair". The distributors are advised to communicate this Product Alert to their customers if the devices were further distributed. For customers in US and Canada, distributors are advised to provide the electronic Excel file with customer's name, address, serial number and part number to WA2221@Stericycle.com. For customers in other countries, they are advised to provide information to PIC50Product Alert@welchallyn.com Consignees can call Welch Allyn at 800-289-2500 for any questions during normal business hours.

Device

  • 모델명 / 제조번호(시리얼번호)
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85334, 85337, 85338, 85340, 85341, 85342, 85343, 85344, 85345, 85346, 85347, 85348, 85349, 85350, 85364, 85365, 85368, 85369, 85381, 85388, 85389, 85391, 85392, 85393, 85394, 85395, 85396, 85397, 85398, 85402, 85403, 85404, 85410, 85411, 85412, 85413, 85414, 85420, 85421, 85422, 85423, 85424, 85425, 85426, 85427, 85428, 85429, 85430, 85431, 85432, 85433, 85441, 85505, 85506, 85507, 85508, 85509, 85510, 85511, 85512, 85513, 85514, 85515, 85517, 85518, 85519, 85520, 85522, 85523, 85524, 85525, 85526, 85527, 85528, 85529, 85530, 85552, 85554, 85555, 85556, 85557, 85587, 85588, 85589, 85602, 85603, 85604, 85604, 85605, 85606, 85607, 85619, 85620, 85621, 85622, 85623, 85630, 85645, 85660, 85686, 85728, 85729, 85730, 85731, 85732, 85733, 85734, 85755, 85756, 85757, 85761, 85762, 85763, 85764, 85765, 85766, 85771, 85771, 85772, 85772, 85773, 85773, 85774, 85774, 85775, 85775, 85776, 85776, 85777, 85778, 85778, 85779, 85779, 85780, 85780, 85781, 85782, 85783, 85784, 85785, 85787, 85788, 85789. 85790, 85791, 85792, 85793, 85810, 85812, 85813, 85814, 85815, 85816, 85817, 85818, 85819, 85820, 85821, 85822, 85823, 85825, 85826, 85827, 85828, 85829, 85830, 85831, 85832, 85833, 85834, 85835, 85836, 85837, 85838, 85856, 85857, 85858, 85859, 85860, 85861, 85862, 85863, 85864, 85865, 85866, 85867, 85868, 85869, 85870, 85871, 85872, 85877, 85878, 85879, 85880, 85881, 85882, 85883, 85884, 85888, 85889, 85890, 85891, 85892, 85893, 85894, 85895, 85896, 85897, 85898, 85899, 85900, 85901, 85902, 85931, 85932, 85933, 85945, 85955, 85964, 85967, 85968, 85969, 85970, 86017, 86018, 86024, 86025, 86026, 86027, 86028, 86029, 86055, 86056, 86057, 86103, 86104, 86118, 86141, 86142, 86143, 86144, 86145, 86146, 86147, 86149, 86150, 86222, 86223, 86224, 86225, 86226, 86227, 86228, 86230, 86245, 86256, 86257, 86258, 86261, 86262, 86263, 86264, 86265, 86266, 86267, 86268, 86281, 86282, 86283, 86289, 86290, 86291, 86292, 86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320, 86321, 86322, 86323, 86324, 86325, 86326, 86327, 86328, 86334, 86335, 86358, 86359, 86385, 86387, 86388, 86389, 86390, 86391, 86392, 86393, 86394, 86395, 86396, 86397, 86398, 86399, 86400, 86411, 86412, 86419, 86420, 86489, 86490, 86491, 86495, 86496, 86497, 86498, 86499, 86533, 86534, 86535, 86536, 86537, 86538, 86539, 86540, 86541, 86542, 86543, 86544, 86545, 86546, 86562, 86563, 86564, 86575, 86599, 86600, 86640, 86641, 86642, 86643, 86644, 86650, 86651, 86663, 86664, 86665, 86666, 86667, 86668, 86669, 86676, 86677, 86678, 86683, 86684, 86696, 86711, 86712, 86713, 86714, 86715, 86716, 86717, 86718, 86767, 86768, 86769, 86770, 86771, 86778, 86819, 86835, 86836, 86837, 86838, 86840, 86848, 86851, 86871, 86872, 86873, 86874, 86875, 86876, 86877, 86878, 86879, 86880, 86881, 86882, 86883, 86973, 86999, 87000, 87001, 87002, 87003, 87004, 87005, 87007, 87008, 87009, 87010, 87011, 87012, 87012, 87013, 87014, 87015, 87027, 87029, 87030, 87309, 87310, 87327, 87328, 87329, 87330, 87331, 87332, 87333, 87334, 87335, 87336, 87337, 87338, 87339, 87340, 87341, 87342, 87343, 87344, 87345, 87347, 87348, 87349, 87350, 87351, 87352, 87403, 87404, 87413, 87414, 87415, 87416, 87417, 87418, 87420, 87572, 87573, 87574, 87575, 87584, 87588, 87589, 87590, 87591, 87592, 87593, 87594, 87595, 87596, 87597, 87598, 87599, 87600, 87601, 87602, 87603, 87604, 87605, 87606, 87607, 87632, 87633, 87667, 87668, 87669, 87670, 87671, 87683, 87684, 87685, 87686, 87687, 87688, 87689, 87690, 87691, 87692, 87693, 87694, 87695, 87696, 87697, 87698, 87699, 87700, 87701, 87702, 87703, 87704, 87705, 87706, 87707, 87708, 87728, 87729, 87730, 87731, 87732, 87733, 87734, 87735, 87736, 87737, 87738, 87739, 87740, 87741, 87742, 87776, 87777, 87778, 87779, 87780, 87781, 87782, 87783, 87789, 87790, 87792, 87793, 87794, 87795, 87796, 89003, 89004, 89005, 89006, 89007, 89008, 89009, 89010, 89011, 89012, 89013, 89014, 89015, 89016, 89020, 89021, 89022, 89023, 89026, 89027, 89028, 89029, 89030, 89033, 89034, 89035, 89054, 89056, 89057, 89058, 89059, 89060, 89061, 89062, 89063, 89064, 89065, 89073, 89074, 89075, 89076, 89077, 89078, 89081, 89082, 89083, 89084, 89085, 89086, 89087, 89088, 89089, 89090, 89091, 89092, 89093, 89094, 89095, 89096, 89097, 89098, 89099, 89100, 89101, 89102, 89103, 89104, 89119, 89120, 89121, 89122, 89123, 89124, 89125, 89126, 89127, 89142, 89143, 89144, 89145, 89146, 89147, 89148, 89149, 89150, 89151, 89152, 89153, 89154, 89155, 89156, 89157, 89158, 89159, 89160, 89161, 89162, 89163, 89164, 89165, 89166. 89186, 89187, 89188, 89189, 89190, 89191, 89192, 89193, 89194, 89197, 89198, 89199, 89219, 89220, 89221, 89222, 89223, 89224, 89225, 89232, 89233, 89234, 89235, 89236, 89237, 89238, 89240, 89251, 89252, 89253, 89254, 89256, 89299, 89300, 89301, 89302, 89303, 89304, 89305, 89306, 89307, 89308, 89331, 89332, 89334, 89336, 89337, 89349, 89350, 89351, 89352, 89353, 89354, 89355, 89356, 89357, 89358, 89359, 89366, 89366, 89367, 89368, 89399, 89400, 89402, 89403, 89404, 89405, 89406, 89407, 89412, 89413, 89414, 89420, 89480, 89502, 89505, 89506, 89507, 89508, 89509, 89510, 89511, 89511, 89512, 89512, 89513, 89513, 89534, 89535, 89536, 89562, 89563, 89564, 89605, 89606, 89610, 89646, 89647, 89648, 89686, 89687, 89688, 89689, 89718, 89719, 89720, 89761, 89762, 89793, 89815, 89816, 89817, 89818, 89819, 89820, 89821, 89822, 89863, 89881, 89882, 89922, 89923, 89924, 89927, 89928, 89929, 89930, 89931, 89932, 89933, 89934, 89935, 89936, 89937, 89938, 89939, 89940, 90002, 90003, 90004, 90005, 90006, 90007, 90008, 90009, 90010, 90011, 90012, 90013, 90014, 90015, 90020, 90030, 90031, 90032, 90033, 90034, 90035, 90036, 90037, 90047, 90048, 90049, 90050, 90051, 90052, 90053, 90054, 90055, 90056, 90057, 90058, 90059, 90060, 90063, 90064, 90066, 90067, 90074, 90080, 90081, 90164, 90165, 90166, 90209, 90210, 90211, 90212, 90213, 90271, 90272, 90273, 90308, 90309, 90320, 90321, 90322, 90364, 90365, 90366, 90402, 90403, 90404, 90405, 90406, 90407, 90408, 90409, 90410, 90411, 90412, 90413, 90414, 90415, 90416, 90417, 90503, 90504, 90505, 90506, 90507, 90508, 90510, 90511, 90516, 90517, 90518, 90519, 90533, 90534, 90562, 90570, 90571, 90572, 90573, 90637, 90700, 90712, 90724, 90725, 90726, 90731, 90732, 90733, 90734, 90735, 90736, 90737, 90738, 90739, 90740, 90741, 90742, 90743, 90744, 90745, 90746, 90747, 90748, 90749, 90750, 90751, 90752, 90753, 90754, 90755, 90756, 90757, 90758, 90759, 90760, 90761, 90762, 90763, 90764, 90765, 90766, 90796, 90797, 90840, 90888, 90889, 90890, 90891, 90900, 90901, 90934, 90935, 90960, 90961, 90962, 90963, 90964, 90969, 90970, 90971, 91079, 91129, 91140, 91141, 91142, 91143, 91144, 91145, 91146, 91147, 91148, 91149, 91150, 91151, 91152, 91154, 91155, 91156, 91199, 91200, 91201, 91202, 91233, 91234, 91235, 91238, 91290, 91295, 91446, 91447, 91495, 91498, 91499, 91500, 91503, 91505, 91506, 91507, 91508, 91509, 91536, 91569, 91570, 91571, 91572, 91575, 91576, 91577, 91578, 91579, 91580, 91581, 91582, 91583, 91585, 91587, 91588, 91589, 91590, 91591, 91592, 91593, 91594, 91595, 91598, 91599, 91600, 91601, 91602, 91603, 91604, 91606, 91607, 91608, 91608, 91609, 91610, 91610, 91611, 91612, 91613, 91615, 91616, 91618, 91619, 91621, 91623, 91624, 91626, 91631, 91632, 91633, 91636, 91637, 91638, 91639, 91640, 91641, 91642, 91643, 91651, 91652, 91653, 91654, 91656, 91657, 91658, 91660, 91661, 91662, 91664, 91665, 91666, 91669, 91670, 91671, 91672, 91675, 91678, 91679, 91681, 91723, 91735, 91736, 91741, 91742, 91743, 91744, 91748, 91749, 91750, 91751, 91752, 91753, 91754, 91755, 91756, 91757, 91758, 91759, 91774, 91775, 91776, 91777, 91778, 91889, 91890, 91891, 91892, 91892, 91893, 91893, 91894, 91895, 91896, 91923, 91924, 92021, 92024, 92105, 92106, 92107, 92108, 92110, 92111, 92113, 92114, 92115, 92116, 92117, 92118, 92119, 92120, 92121, 92122, 92123, 92124, 92125, 92126, 92127, 92128, 92129, 92130, 92131, 92132, 92133, 92134, 92135, 92135, 92136, 92137, 92138, 92139, 92140, 92141, 92142, 92143, 92144, 92145, 92146, 92147, 92148, 92149. 92150, 92151, 92152, 92153, 92154, 92155, 92156, 92157, 92158, 92159, 92160, 92161, 92162, 92195, 92219, 92220, 92224, 92225, 92226, 92227, 92228, 92229, 92230, 92235, 92236, 92237, 92238, 92239, 92242, 92243, 92246, 92247, 92253, 92254, 92257, 92258, 92259, 92259, 92260, 92260, 92261, 92262, 92263, 92264, 92265, 92316, 92317, 92318, 92319, 92320, 92321, 92322, 92323, 92324, 92325, 92326, 92327, 92328, 92329, 92330, 92331, 92332, 92333, 92334, 92335, 92336, 92337, 92339, 92340, 92340, 92341, 92342, 92343, 92344, 92345, 92346, 92348, 92364, 92364, 92365, 92365, 92366, 92367, 92368, 92369, 92371, 92371, 92372, 92373, 92424, 92439, 92440, 92462, 92463, 92477, 92478, 92479, 92480, 92522, 92538, 92539, 92540, 92541, 92542, 92548, 92549, 92550, 92551, 92552, 92557, 92558, 92559, 92565, 92566, 92567, 92568, 92568, 92569, 92570, 92570, 92571, 92572, 92572, 92573, 92573, 92574, 92575, 92576, 92577, 92578, 92579, 92580, 92582, 92583, 92584, 92585, 92586, 92587, 92588, 92589, 92590, 92591, 92592, 92593, 92594, 92595, 92596, 92597, 92598, 92599, 92600, 92601, 92602, 92603, 92604, 92605, 92606, 92607, 92608, 92658, 92659, 92659, 92660, 92662, 92663, 92667, 92668, 92669, 92670, 92671, NF160001, NF160001, NF160002, NF160002, NF160003, NF160003, NF160004, NF160004, NF160005, NF160005, NF160006, NF160006, NF160007, NF160007, NF160008, NF160008, NF160009, NF160009, NF160010, NF160010, NF160011, NF160011, NF160012, NF160013, NF160014, NF160015, NF160016, NF160017, NF160018, NF160019, NF160020, NF160021, NF160022, NF160023, NF160024, NF160025, NF160026, NF160027, NF160028, NF160029, NF160030, NF160031, NF160032, NF160033, NF160034, NF160035, NF160036, NF160037, NF160038, NF160039, NF160040, NF160041, NF160042, NF160043, NF160044, NF160045, NF160046, NF160047, NF160048, NF160049, NF160050, NF160051, NF160053, NF160054, NF160055, NF160056, NF160057, NF160058, NF160059, NF160060, NF160061, NF160062, NF160063, NF160064, NF160065, NF160066, NF160067, NF160068, NF160069, NF160070, NF160071, NF160072, NF160073, NF160074, NF160075, NF160076, NF160077, NF160078, NF160079, NF160080, NF160081, NF160082, NF160083, NF160084, NF160085, NF160086, NF160087, NF160088, NF160089, NF160090, NF160091, NF160092, NF160093, NF160094, NF160095, NF160096, NF160097, NF160098, NF160099, NF160100, NF160101, NF160102, NF160103, NF160104, NF160105, NF160106, NF160107, NF160108, NF160109, NF160110, NF160111, NF160112, NF160113, NF160114, NF160115, NF160116, NF160117, NF160118, NF160119, NF160120, NF160121, NF160122, NF160123, NF160124, NF160125, NF160126, NF160127, NF160128, NF160129, NF160130, NF160131, NF160132, NF160133, NF160134, NF160135, NF160136, NF160137, NF160138, NF160139, NF160140, NF160141, NF160142, NF160143, NF160144, NF160145, NF160146, NF160147, NF160148, NF160149, NF160150, NF160151, NF160152, NF160153, NF160154, NF160155, NF160156, NF160157, NF160158, NF160159, NF160160, NF160161, NF160162, NF160163, NF160164, NF160165, NF160166, NF160167, NF160168, NF160169, NF160170, NF160171, NF160172, NF160173, NF160174, NF160175, NF160176, NF160177, NF160178, NF160179, NF160180, NF160181, NF160182, NF160183, NF160184, NF160185, NF160186, NF160187, NF160188, NF160189, NF160190, NF160191, NF160192, NF160193, NF160194, NF160195, NF160196, NF160197, NF160198, NF160199, NF160200, NF160201, NF160202, NF160203, NF160204, NF160205, NF160206, NF160207, NF160208, NF160209, NF160210, NF160211, NF160212, NF160213, NF160214, NF160215, NF160216, NF160217, NF160218, NF160219, NF160220, NF160221, NF160222, NF160223, NF160224, NF160225, NF160226, NF160227, NF160228, NF160229, NF160230. NF160231, NF160232, NF160233, NF160234, NF160235, NF160236, NF160237, NF160238, NF160239, NF160240, NF160241, NF160242, NF160243, NF160244, NF160245, NF160246, NF160247, NF160248, NF160249, NF160250, NF160251, NF160252, NF160253, NF160254, NF160255, NF160256, NF160257, NF160258, NF160259, NF160260, NF160261, NF160262, NF160263, NF160264, NF160265, NF160266, NF160267, NF160268, NF160269, NF160270, NF160271, NF160272, NF160273, NF160274, NF160275, NF160276, NF160277, NF160278, NF160279, NF160280, NF160281, NF160282, NF160283, NF160284, NF160285, NF160286, NF160287, NF160288, NF160289, NF160290, NF160291, NF160292, NF160293, NF160294, NF160295, NF160296, NF160297, NF160298, NF160299, NF160300, NF160301, NF160302, NF160303, NF160304, NF160305, NF160306, NF160307, NF160308, NF160309, NF160310, NF160311, NF160312, NF160313, NF160314, NF160315, NF160316, NF160317, NF160318, NF160319, NF160320, NF160321, NF160322, NF160323, NF160324, NF160325, NF160326, NF160327, NF160328, NF160329, NF160330, NF160331, NF160332, NF160333, NF160334, NF160335, NF160336, NF160337, NF160338, NF160339, NF160340, NF160341, NF160342, NF160343, NF160344, NF160345, NF160346, NF160347, NF160348, NF160349, NF160350, NF160351, NF160352, NF160353, NF160354, NF160355, NF160356, NF160357, NF160358, NF160359, NF160360, NF160361, NF160362, NF160363, NF160364, NF160365, NF160366, NF160367, NF160368, NF160369, NF160370, NF160371, NF160372, NF160373, NF160374, NF160375, NF160376, NF160379, NF160380, NF160381, NF160382, NF160383, NF160384, NF160385, NF160386, NF160387, NF160388, NF160389, NF160390, NF160391, NF160392, NF160393, NF160394, NF160395, NF160396, NF160397, NF160400, NF160401, NF160402, NF160403, NF160404, NF160405, NF160406, NF160407, NF160408, NF160409, NF160410, NF160411, NF160412, NF160413, NF160414, NF160415, NF160416, NF160417, NF160418, NF160419, NF160420, NF160421, NF160422, NF160423, NF160424, NF160425, NF160426, NF160427, NF160428, NF160429, NF160430, NF160431, NF160432, NF160433, NF160434, and P1011.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US, including states: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and countries of Australia, Austria, Belgium, Canada, China, Columbia, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Mexico, Oman, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam, and Yemen.
  • 제품 설명
    Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. || Designed for use in and out of the hospital.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • 제조사 모회사 (2017)
  • Source
    USFDA