Recall of Welch Allyn PIC 50 Portable Intensive Care System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Welch Allyn Protocol, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56804
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2011
  • Event Initiated Date
    2010-09-17
  • Event Date Posted
    2011-01-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-07-25
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    External Transcutaneous Cardiac Pacemaker (Non-Invasive) - Product Code DRO
  • Reason
    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

  • Model / Serial
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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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. || Designed for use in and out of the hospital.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Manufacturer Parent Company (2017)
  • Source
    USFDA