Rappel de Welch Allyn PIC 50 Portable Intensive Care System

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
    56804
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0937-2011
  • Date de mise en oeuvre de l'événement
    2010-09-17
  • Date de publication de l'événement
    2011-01-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-07-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    External Transcutaneous Cardiac Pacemaker (Non-Invasive) - Product Code DRO
  • Cause
    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.
  • Action
    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

  • Modèle / numéro de série
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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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. || Designed for use in and out of the hospital.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Société-mère du fabricant (2017)
  • Source
    USFDA