Class 2 Device Recall Welch Allyn PIC 50 Portable Intensive Care System

• Date Initiated by Firm: September 17, 2010
• Date Posted: January 24, 2011
• Recall Status: Terminated on July 25, 2011
• Recall Number: Z-0937-2011
• Recall Event ID: 56804
• 510(K)Number: K974034
• Product Classification: External Transcutaneous Cardiac Pacemaker (Non-Invasive) - Product Code DRO
• Product: Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series.; ; Designed for use in and out of the hospital.
• Code Information: Devices are identified with Serial Numbers: 1005, 1011, 1012, 1013, 1014, 2355, 80001, 80003, 80007, 80008, 80009, 80012, 80013, 80018, 80022, 80025, 80031, 80032, 80033, 80035, 80042, 80045, 80050, 80059, 80076, 80085, 80117, 80228, 80276, 80281, 80282, 80283, 80285, 80286, 80288, 80289, 80290, 80296, 80297, 80298, 80299, 80301, 80314, 80315, 80316, 80317, 80318, 80319, 80347, 80348, 80349, 80350, 80351, 80352, 80353, 80354, 80355, 80356, 80357, 80358, 80359, 80360, 80361, 80362, 80363, 80364, 80365, 80366, 80367, 80368, 80369, 80370, 80371, 80372, 80373, 80374, 80375, 80376, 80378, 80379, 80380, 80381, 80383, 80384, 80385, 80386, 80387, 80388, 80389, 80390, 80391, 80392, 80393, 80394, 80395, 80405, 80406, 80407, 80408, 80419, 80420, 80423, 80424, 80425, 80426, 80427, 80428, 80429, 80430, 80431, 80432, 80433, 80434, 80435, 80436, 80437, 80438, 80439, 80440, 80441, 80443, 80444, 80445, 80446, 80447, 80448, 80449, 80450, 80451, 80453, 80454, 80455, 80456, 80458, 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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.
• Recalling Firm/ Manufacturer: Welch Allyn Protocol, Inc; 8500 Sw Creekside Pl; Beaverton OR 97008
• For Additional Information Contact: ZOLL Medical Corporation; 503-530-7935
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 2002 units to US consignees and 1604 units to foreign consignees
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DRO and Original Applicant = MEDICAL RESEARCH LABORATORIES, INC.