Class 2 Device Recall Propaq LT 802LT series Vital Signs Monitor

• Date Initiated by Firm: November 21, 2013
• Date Posted: January 07, 2014
• Recall Status: Terminated on February 17, 2015
• Recall Number: Z-0633-2014
• Recall Event ID: 66919
• 510(K)Number: K033378
• Product Classification: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) - Product Code MWI
• Product: The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN.; ; These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications.; ; intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
• Code Information: SERIAL NUMBERS OF DEVICES DISTRIBUTED IN THE US: KA008788, KA009581, KA009685, KA009776, KA009917, KA010079, KA010193, KA010996, KA011141, KA011192, KA011227, KA011228, KA011231, KA011249, KA011303, KA011307, KA011311, KA011314, KA011327, KA011355, KA011356, KA011609, KA011610, KA011611, KA011667, KA011671, KA011672, KA011673, KA011674, KA011675, KA011676, KA011677, KA011678, KA011682, KA011731, KA011758, KA020006, KA020007, KA020008, KA020009, KA020010, KA020011, KA020012, KA020013, KA020014, KA020015, KA020016, KA020018, KA020023, KA020088, KA020091, KA020092, KA020093, KA020116, KA020135, KA020140, KA020149, KA020150, KA020151, KA020192, KA020200, KA020206, KA020207, KA020208, KA020209, KA020210, KA020211, KA020212, KA020213, KA020214, KA020215, KA020262, KA020264, KA020265, KA020266, KA020269, KA020270, KA020273, KA020295, KA020299, KA020304, KA020310, KA020311, KA020313, KA020314, KA020321, KA020381, KA020385, KA020386, KA020387, KA020388, KA020389, KA020390, KA020391, KA020392, KA020393, KA020394, KA020405, KA020406, KA020407, KA020408, KA020409, KA020410, KA020411, KA020412, KA020413, KA020414, KA020417, KA020422, KA020423, KA020424, KA020425, KA020426, KA020427, KA020429, KA020430, KA020432, KA020433, KA020435, KA020436, KA020437, KA020438, KA020439, KA020442, KA020443, KA020444, KA020445, KA020446, KA020447, KA020448, KA020449, KA020450, KA020451, KA020452, KA020453, KA020454, KA020455, KA020456, KA020457, KA020458, KA020459, KA020460, KA020461, KA020462, KA020463, KA020464, KA020465, KA020466, KA020467, KA020468, KA020469, KA020470, KA020471, KA020472, KA020473, KA020474, KA020475, KA020477, KA020478, KA020479, KA020480, KA020481, KA020482, KA020483, KA020526, KA020529, KA020532, KA020533, KA020534, KA020535, KA020536, KA020537, KA020538, KA020540, KA020541, KA020542, KA020543, KA020545, KA020546, KA020547, KA020548, KA020549, KA020550, KA020551, KA020552, KA020553, KA020554, KA020555, KA020556, KA020557, KA020558, KA020559, KA020560, KA020561, KA020562, KA020563, KA020564, KA020575, KA020576, KA020577, KA020578, KA020581, KA020582, KA020595, KA020596, KA020597, KA020606, KA020611, KA020613, KA020617, KA020631, KA020632, KA020633, KA020641, KA020646, KA020649, KA020650, KA020655, KA020659, KA020666, KA020685, KA020691, KA020692, KA020693, KA020726, KA020729, KA020742, KA020743, KA020746, KA020748, KA020853, KA020908, KA020909, KA020916, KA020917, KA021019, KA021028, KA021043, KA021048, KA021061, KA021062, KA021063, KA021064, KA021065, KA021086, KA021126, KA021151, KA021155, KA021158, KA021159, KA021170, KA021181, KA021182, KA021184, KA021188, KA021190, KA021202, KA021221, KA021277, KA021278, KA021279, KA021280, KA021286, KA021294, KA021298, KA021299, KA021311, KA021312, KA021313, KA021318, KA021319, KA021322, KA021323, KA021327, KA021330, KA021349, KA021365, KA021366, KA021367, KA021368, KA021369, KA021370, KA021371, KA021392, KA021393, KA021394, KA021395, KA021396, KA021397, KA021398, KA021399, KA021401, KA021402, 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KA022166, KA022167, KA022168, KA022169, KA022172, KA022174, KA022175, KA022176, KA022178, KA022179, KA022180, KA022182, KA022183, KA022184, KA022185, KA022186, KA022187, KA022188, KA022189, KA022190, KA022191, KA022192, KA022193, KA022194, KA022195, KA022196, KA022197, KA022198, KA022199, KA022200, KA022201, KA022202, KA022203, KA022204, KA022205, KA022206, KA022207, KA022208, KA022209, KA022210, KA022211, KA022212, KA022213, KA022214, KA022215, KA022216, KA022217, KA022218, KA022219, KA022220, KA022221, KA022222, KA022223, KA022224, KA022225, KA022232, KA022233, KA022234, KA022235, KA022236, KA022237, KA022238, KA022239, KA022240, KA022241, KA022244, KA022246, KA022277, KA022279, KA022283, KA022286, KA022310, KA022311, KA022312, KA022313, KA022314, KA022315, KA022355, KA022356, KA022358, KA022468, KA022474, KA022481, KA022482, KA022484, KA022485, KA022486, KA022488, KA022489, KA022512, KA022513, KA022514, KA022515, KA022516, KA022517, KA022518, KA022520, KA022522, KA022524, KA022527, KA022528, KA022560, KA022581, KA022591, KA022592, KA022593, KA022594, KA022595, KA022596, KA022610, KA022612, KA022614, KA022619, KA022621, KA022622, KA022623, KA022624, KA022625, KA022626, KA022627, KA022628, KA022629, KA022630, KA022631, KA022632, KA022633, KA022634, KA022635, KA022636, KA022637, KA022638, KA022639, KA022640, KA022641, KA022642, KA022643, KA022644, KA022645, KA022646, KA022647, KA022648, KA022649, KA022650, KA022651, KA022652, KA022653, KA022654, KA022655, KA022656, KA022657, KA022658, KA022659, KA022660, KA022661, KA022662, KA022663, KA022664, KA022665, KA022666, KA022667, KA022668, KA022671, KA022673, KA022674, KA022676, KA022677, KA022678, KA022679, KA022680, KA022681, KA022682, KA022683, KA022684, KA022685, KA022686, KA022687, KA022688, KA022689, KA022690, KA022691, KA022692, KA022693, KA022694, KA022695, KA022696, KA022697, KA022698, KA022699, KA022700, KA022701, KA022702, KA022703, KA022704, KA022705, KA022706, KA022707, KA022708, KA022709, KA022710, KA022711, KA022712, KA022713, KA022714, KA022715, KA022716, KA022717, KA022718, KA022719, KA022720, KA022721, KA022722, KA022723, KA022724, KA022725, KA022726, KA022727, KA022728, KA022729, KA022730, KA022731, KA022732, KA022733, KA022734, KA022736, KA022737, KA022741, KA022743, KA022744, KA022745, KA022746, KA022747, KA022748, KA022752, KA022753, KA022754, KA022755, KA022756, KA022757, KA022758, KA022759, KA022761, KA022762, KA022763, KA022764, KA022765, KA022766, KA022767, KA022768, KA022769, KA022770, KA022771, KA022772, KA022773, KA022774, KA022775, KA022776, KA022777, KA022778, KA022779, KA022780, KA022781, KA022782, KA022783, KA022784, KA022786, KA022788, KA022789, KA022790, KA022793, KA022795, KA022802, KA022803, KA022805, KA022806, KA022808, KA022809, KA022810, KA022811, KA022812, KA022813, KA022814, KA022815, KA022816, KA022818, KA022819, KA022820, KA022821, KA022822, KA022823, KA022824, KA022825, KA022826, KA022827, KA022828, KA022829, KA022830, KA022831, KA022832, KA022833, KA022834, KA022835, KA022836, KA022837, KA022838, KA022839, KA022840, KA022841, KA022842, KA022844, KA022845, KA022846, KA022847, KA022848, KA022849, KA022850, KA022851, KA022852, KA022853, KA022854, KA022855, KA022856, KA022857, KA022858, KA022859, KA022860, KA022861, KA022862, KA022863, KA022864, KA022865, KA022866, KA022867, KA022868, KA022869, KA022870, KA022871, KA022872, KA022873, KA022874, KA022875, KA022876, KA022877, KA022878, KA022879, KA022880, KA022881, KA022882, KA022883, KA022884, KA022885, KA022886, KA022887, KA022888, KA022889, KA022890, KA022891, KA022892, KA022893, KA022894, KA022895, KA022903, KA022904, KA022905, KA022906, KA022908, KA022909, KA022911, KA022912, KA022913, KA022914, KA022915, KA022917, KA022920, KA022943, KA022958, KA022973, KA022974, KA022975, KA022976, KA022984, KA022985, KA022986, KA023057, KA023058, KA023061, KA023063, KA023064, KA023065, KA023067, KA023068, KA023069, KA023070, KA023071, KA023072, KA023073, KA023075, KA023078, KA023080, KA023081, KA023082, 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KA023844, KA023845, KA023846, KA023847, KA023848, KA023849, KA023851, KA023855, KA023858, KA023859, KA023863, KA023865, KA023866, KA023867, KA023868, KA023870, KA023882, KA023884, KA023885, KA023886, KA023887, KA023888, KA023889, KA023890, KA023923, KA023955, KA023957, KA023976, KA023986, KA023992, KA023994, KA023997, KA024003, KA024014, KA024017, KA024018, KA024022, KA024023, KA024025, KA024051, KA024054, KA024071, KA024093, KA024107, KA024145, KA024171, KA024193, KA024200, KA024201, KA024202, KA024203, KA024204, KA024205, KA024206, KA024207, KA024208, KA024209, KA024210, KA024211, KA024212, KA024225, KA024227, KA024228, KA024229, KA024230, KA024231, KA024232, KA024233, KA024235, KA024236, KA024237, KA024239, KA024240, KA024241, KA024246, KA024247, KA024248, KA024249, KA024250, KA024251, KA024252, KA024253, KA024255, KA024259, KA024260, KA024263, KA024267, KA024269, KA024276, KA024282, KA024283, KA024284, KA024285, KA024286, KA024287, KA024298, KA024300, KA024301, KA024302, KA024303, KA024304, KA024305, KA024306, KA024307, KA024308, KA024310, KA024311, KA024312, KA024313, KA024314, KA024315, KA024316, KA024318, KA024319, KA024321, KA024322, KA024323, KA024324, KA024325, KA024327, KA024331, KA024332, KA024333, KA024334, KA024335, KA024339, KA024343, KA024344, KA024345, KA024351, KA024353, KA024355, KA024369, KA024370, KA024374, KA024375, KA024377, KA024378, KA024379, KA024380, KA024381, KA024382, KA024383, KA024384, KA024385, KA024386, KA024387, KA024388, KA024389, KA024390, KA024391, KA024392, KA024393, KA024394, KA024395, KA024397, KA024399, KA024400, KA024406, KA024407, KA024421, KA024433, KA024436, KA024439, KA024440, KA024441, KA024442, KA024448, KA024449, KA024452, KA024484, KA024485, KA024490, KA024491, KA024492, KA024498, KA024499, KA024500, KA024503, KA024505, KA024506, KA024509, KA024510, KA024512, KA024514, KA024516, KA024517, KA024518, KA024519, KA024521, KA024522, KA024523, KA024524, KA024594, KA024617, KA024618, KA024619, KA024620, KA024621, KA024622, KA024623, KA024624, KA024625, KA024626, KA024627, KA024628, KA024629, KA024662, KA024666, KA024668, KA024798, KA024801, KA024804, KA024807, KA024809, KA024811, KA024813, KA024814, KA024817, KA024822, KA024870, KA024871, KA024873, KA024900, KA024902, KA024908, KA024915, KA024919, KA024921, KA024922, KA024943, KA024944, KA024945, KA024946, KA024947, KA024948, KA024949, KA024950, KA024951, KA024992, KA024997, KA024998, KA024999, KA025001, KA025003, KA025004, KA025010, KA025011, KA025012, KA025013, KA025016, KA025031, KA025035, KA025041, KA025043, KA025053, KA025062, KA025064, KA025089, KA025090, KA025092, KA025093, KA025095, KA025096, KA025126, KA025144, KA025145, KA025159, KA025160, KA025168, KA025177, KA025180, KA025181, KA025182, KA025183, KA025184, KA025185, KA025186, KA025191, KA025203, KA025204, KA025205, KA025226, KA025229, KA025230, KA025231, KA025232, KA025233, KA025235, KA025236, KA025238, KA025239, KA025240, KA025241, KA025262, KA025263, KA025264, KA025265, KA025266, KA025267, KA025268, KA025269, KA025272, KA025275, KA025280, KA025282, KA025296, KA025302, KA025304, KA025305, KA025306, KA025307, KA025308, KA025309, KA025310, KA025311, KA025312, KA025313, KA025314, KA025315, KA025316, KA025317, KA025318, KA025319, KA025320, KA025321, KA025322, KA025323, KA025325, KA025326, KA025327, KA025330, KA025355, KA025428, KA025433, KA025434, KA025435, KA025436, KA025437, KA025448, KA025510, KA025524, KA025535, KA025578, KA025579, KA025580, KA025581, KA025614, KA025615, KA025616, KA025617, KA025629, KA025733, KA025734, KA025735, KA025736, KA025737, KA025740, KA025875, KA025876, KA025877, KA025879, KA025891, KA025892, KA025898, KA025902, KA025903, KA025908, KA025909, KA025910, KA025911, KA025912, KA025938, KA025939, KA026024, KA026028, KA026029, KA026041, KA026042, KA026045, KA026046, KA026048, KA026049, KA026050, KA026052, KA026053, KA026054, KA026056, KA026057, KA026058, KA026059, KA026062, KA026063, KA026105, KA026107, KA026108, KA026110, KA026111, KA026140, KA026141, KA026142, KA026143, KA026151, KA026152, KA026154, KA026157, KA026178, KA026179, KA026180, KA026181, KA026182, KA026184, KA026263, KA026264, KA026265, KA026278, KA026287, KA026288, KA026302, KA026370, KA026371, KA026372, KA026373, KA026375, KA026376, KA026377, KA026378, KA026379, KA026406, KA026407, KA026408, KA026409, KA026410, KA026412, KA026416, KA026457, KA026499, KA026502, KA026503, KA026504, KA026505, KA026506, KA026507, KA026508, KA026509, KA026573, KA026574, KA026575, KA026576, KA026638, KA026639, KA026751, KA026752, KA026753, KA026763, KA026766, KA026771, KA026774, KA026797, KA026815, KA026816, KA026817, KA026818, KA026819, KA026820, KA026821, KA026822, KA026823, KA026824, KA026825, KA026826, KA026838, KA026849, KA026854, KA026856, KA026857, KA026869, KA026872, KA026933, KA026938, KA026939, KA026941, KA026942, KA026944, KA026945, KA026946, KA026948, KA026950, KA026951, KA026952, KA026953, KA026954, KA026955, KA026956, KA026957, KA026958, KA026959, KA026960, KA026961, KA026962, KA026963, KA026964, KA026985, KA026987, KA026992, KA027029, KA027031, KA027032, KA027033, KA027045, KA027130, KA027134, KA027135, KA027136, KA027137, KA027138, KA027147, KA027148, KA027157, KA21398, KA21399, and KA21407. SERIAL NUMBERS OF DEVICES DISTRIBUTED OUTSIDE THE US: KA002129, KA002130, KA008395, KA008397, KA008401, KA008600, KA008715, KA008794, KA009204, KA009205, KA009208, KA009212, KA009260, KA009268, KA009350, KA009393, KA009394, KA009395, KA009396, KA009397, KA009399, KA009400, KA009402, KA009404, KA009406, KA009407, KA009408, KA009429, KA009438, KA009446, KA009449, KA009451, KA009452, KA009457, KA009458, KA009470, KA009504, KA009572, KA009575, KA009578, KA009579, KA009587, KA009611, KA009665, KA009666, KA009667, KA009668, KA009669, KA009671, KA009672, KA009675, KA009677, KA009690, KA009693, KA009699, KA009707, KA009708, KA009755, KA009796, KA009822, KA009826, KA009827, KA009829, KA009896, KA009897, KA009913, KA009946, KA010203, KA010362, KA010366, KA010370, KA010448, KA010496, KA010548, KA010596, KA010753, KA010787, KA010788, KA010795, KA010835, KA010836, KA010922, KA010923, KA011029, KA011071, KA011075, KA011095, KA011120, KA011150, KA011161, KA011186, KA011189, KA011209, KA011210, KA011211, KA011212, KA011215, KA011218, KA011229, KA011232, KA011263, KA011276, KA011283, KA011394, KA011396, KA011397, KA011399, KA011401, KA011402, KA011403, KA011404, KA011405, KA011409, KA011410, KA011411, KA011412, KA011413, KA011414, KA011416, KA011417, KA011418, KA011419, KA011420, KA011422, KA011423, KA011424, KA011425, KA011426, KA011427, KA011428, KA011430, KA011431, KA011432, KA011433, KA011434, KA011435, KA011436, KA011437, KA011438, KA011439, KA011440, KA011448, KA011449, KA011452, KA011463, KA011467, KA011468, KA011469, KA011470, KA011471, KA011472, KA011473, KA011474, KA011475, KA011476, KA011478, KA011479, KA011480, KA011481, KA011482, KA011483, KA011484, KA011485, KA011488, KA011489, KA011490, KA011491, KA011492, KA011493, KA011494, KA011495, KA011496, KA011497, KA011498, KA011500, KA011501, KA011502, KA011503, KA011504, KA011506, KA011507, KA011508, KA011514, KA011571, KA011573, KA011575, KA011576, KA011580, KA011581, KA011582, KA011583, KA011585, KA011586, KA011587, KA011588, KA011589, KA011596, KA011625, KA011640, KA011641, KA011642, KA011643, KA011654, KA011655, KA011657, KA011658, KA011659, KA011660, KA011661, KA011662, KA011663, KA011664, KA011665, KA011666, KA011668, KA011669, KA011670, KA011680, KA011683, KA011703, KA011704, KA011730, KA011735, KA011737, KA011738, KA011741, KA011742, KA011743, KA011745, KA011746, KA011754, KA011755, KA011756, KA011757, KA011760, KA011761, KA011763, KA011765, KA011766, KA011767, KA011768, KA011771, KA011793, KA020017, KA020019, KA020020, KA020021, KA020022, KA020024, KA020025, KA020086, KA020087, KA020089, KA020090, KA020094, KA020095, KA020114, KA020115, KA020117, KA020118, KA020119, KA020120, KA020121, KA020122, KA020123, KA020124, KA020125, KA020126, KA020127, KA020128, KA020129, KA020130, KA020131, KA020132, KA020133, KA020134, KA020136, KA020137, KA020138, KA020139, KA020141, KA020142, KA020143, KA020144, KA020145, KA020146, KA020147, KA020148, KA020152, KA020153, KA020189, KA020190, KA020191, KA020193, KA020196, KA020197, KA020198, KA020199, KA020201, KA020202, KA020203, KA020204, KA020205, KA020231, KA020256, KA020257, KA020258, KA020259, KA020260, KA020261, KA020263, KA020267, KA020268, KA020271, KA020272, KA020274, KA020275, KA020286, KA020287, KA020288, KA020289, KA020290, KA020291, KA020292, KA020293, KA020294, KA020296, KA020297, KA020298, KA020300, KA020301, KA020302, KA020303, KA020305, KA020306, KA020307, KA020308, KA020309, KA020312, KA020315, KA020316, KA020317, KA020318, KA020319, KA020320, KA020322, KA020323, KA020324, KA020325, KA020326, KA020349, KA020350, KA020351, KA020352, KA020353, KA020354, KA020355, KA020356, KA020357, KA020358, KA020373, KA020374, KA020375, KA020376, KA020377, KA020378, KA020379, KA020380, KA020382, KA020383, KA020384, KA020400, KA020401, KA020402, KA020403, KA020404, KA020415, KA020416, KA020418, KA020419, KA020420, KA020421, KA020428, KA020431, KA020434, KA020440, KA020441, KA020476, KA020484, KA020525, KA020527, KA020528, KA020530, KA020531, KA020539, KA020544, KA020579, KA020580, KA020583, KA020584, KA020585, KA020586, KA020587, KA020588, KA020589, KA020590, KA020591, KA020592, KA020593, KA020594, KA020598, KA020599, KA020600, KA020601, KA020602, KA020603, KA020604, KA020605, KA020607, KA020608, KA020609, KA020610, KA020612, KA020614, KA020615, KA020616, KA020618, KA020619, KA020630, KA020634, KA020635, KA020636, KA020637, KA020638, KA020639, KA020640, KA020642, KA020643, KA020644, KA020645, KA020647, KA020648, KA020651, KA020652, KA020653, KA020654, KA020656, KA020657, KA020658, KA020660, KA020661, KA020662, KA020663, KA020664, KA020665, KA020667, KA020668, KA020669, KA020680, KA020681, KA020682, KA020683, KA020684, KA020686, KA020687, KA020688, KA020689, KA020690, KA020694, KA020700, KA020701, KA020702, KA020703, KA020704, KA020705, KA020706, KA020707, KA020708, KA020709, KA020710, KA020711, KA020712, KA020713, KA020714, KA020715, KA020716, KA020717, KA020718, KA020719, KA020720, KA020721, KA020722, KA020723, KA020724, KA020725, KA020727, KA020728, KA020730, KA020731, KA020732, KA020733, KA020734, KA020735, KA020736, KA020737, KA020738, KA020739, KA020740, KA020741, KA020744, KA020745, KA020747, KA020749, KA020750, KA020751, KA020752, KA020753, KA020754, KA020755, KA020756, KA020757, KA020758, KA020759, KA020781, KA020782, KA020783, KA020784, KA020785, KA020786, KA020787, KA020788, KA020789, KA020790, KA020791, KA020792, KA020793, KA020794, KA020795, KA020796, KA020797, KA020798, KA020799, KA020800, KA020801, KA020802, KA020803, KA020804, KA020805, KA020806, KA020807, KA020808, KA020809, KA020810, KA020811, KA020812, KA020813, KA020814, KA020815, KA020816, KA020817, KA020818, KA020819, KA020820, KA020821, KA020822, KA020823, KA020824, KA020825, KA020826, KA020827, KA020828, KA020829, KA020830, KA020831, KA020832, KA020833, KA020834, KA020835, KA020836, KA020837, KA020838, KA020839, KA020840, KA020841, KA020842, KA020843, KA020844, KA020845, KA020846, KA020847, KA020848, KA020849, KA020850, KA020851, KA020852, KA020854, KA020855, KA020856, KA020857, KA020858, KA020859, KA020860, KA020861, KA020862, KA020863, KA020864, KA020865, KA020866, KA020867, KA020868, KA020869, KA020870, KA020871, KA020872, KA020873, KA020874, KA020875, KA020876, KA020877, KA020878, KA020879, KA020880, KA020881, KA020882, KA020883, KA020884, KA020885, KA020886, KA020887, KA020888, KA020889, KA020890, KA020891, KA020892, KA020893, KA020894, KA020895, KA020896, KA020897, KA020898, KA020899, KA020900, KA020901, KA020902, KA020903, KA020904, KA020905, KA020906, KA020907, KA020910, KA020911, KA020912, KA020913, KA020914, KA020915, KA020918, KA020919, KA020920, KA020921, KA020922, KA020923, KA020924, KA020925, KA020926, KA020927, KA020928, KA020929, KA020930, KA020931, KA020932, KA020933, KA020934, KA020935, KA020936, KA020937, KA020938, KA020939, KA020940, KA020941, KA020942, KA020943, KA020944, KA020945, KA020946, KA020947, KA020948, KA020949, KA020950, KA020951, KA020952, KA020953, KA020954, KA020955, KA020956, KA020957, KA020958, KA020959, KA020960, KA020961, KA020962, KA020963, KA020964, KA020965, KA020966, KA020967, KA020968, KA020969, KA020970, KA020971, KA020972, KA020973, KA020974, KA020975, KA020976, KA020977, KA020978, KA020979, KA020980, KA020981, KA020982, KA020983, KA020984, KA020985, KA020986, KA020987, KA020988, KA020989, KA020990, KA020991, KA020992, KA020993, KA020994, KA020995, KA020996, KA020997, KA020998, KA020999, KA021000, KA021001, KA021002, KA021003, KA021004, KA021005, KA021006, KA021007, KA021008, KA021009, KA021010, KA021011, KA021012, KA021013, KA021014, KA021015, KA021016, KA021017, KA021018, KA021020, KA021021, KA021022, KA021023, KA021024, KA021025, KA021026, KA021027, KA021029, KA021030, KA021031, KA021032, KA021033, KA021034, KA021035, KA021036, KA021037, KA021038, KA021039, KA021040, KA021041, KA021042, KA021044, KA021045, KA021046, KA021047, KA021049, KA021050, KA021051, KA021052, KA021053, KA021054, KA021055, KA021056, KA021057, KA021058, KA021059, KA021060, KA021087, KA021088, KA021089, KA021090, KA021091, KA021092, KA021093, KA021094, KA021095, KA021096, KA021097, KA021098, KA021099, KA021100, KA021101, KA021102, KA021103, KA021104, KA021105, KA021106, KA021107, KA021108, KA021109, KA021110, KA021111, KA021112, KA021113, KA021114, KA021115, KA021116, KA021117, KA021118, KA021119, KA021120, KA021121, KA021122, KA021123, KA021124, KA021125, KA021127, KA021128, KA021129, KA021130, KA021131, KA021132, KA021133, KA021134, KA021135, KA021136, KA021137, KA021138, KA021139, KA021140, KA021141, KA021142, KA021143, KA021144, KA021145, KA021146, KA021147, KA021148, KA021149, KA021150, KA021152, KA021153, KA021154, KA021156, KA021157, KA021160, KA021161, KA021162, KA021163, KA021164, KA021165, KA021166, KA021167, KA021168, KA021169, KA021171, KA021172, KA021173, KA021174, KA021175, KA021176, KA021177, KA021178, KA021179, KA021180, KA021183, KA021185, KA021186, KA021187, KA021189, KA021191, KA021192, KA021193, KA021194, KA021195, KA021196, KA021197, 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KA022288, KA022289, KA022290, KA022291, KA022292, KA022293, KA022294, KA022295, KA022296, KA022297, KA022298, KA022299, KA022300, KA022301, KA022302, KA022303, KA022304, KA022305, KA022306, KA022307, KA022308, KA022309, KA022316, KA022317, KA022318, KA022319, KA022320, KA022321, KA022322, KA022323, KA022324, KA022325, KA022326, KA022327, KA022328, KA022329, KA022330, KA022331, KA022332, KA022333, KA022334, KA022335, KA022336, KA022337, KA022338, KA022339, KA022340, KA022341, KA022342, KA022343, KA022344, KA022345, KA022346, KA022347, KA022348, KA022349, KA022350, KA022351, KA022352, KA022353, KA022354, KA022357, KA022359, KA022360, KA022361, KA022362, KA022363, KA022364, KA022365, KA022366, KA022367, KA022402, KA022403, KA022404, KA022405, KA022406, KA022407, KA022408, KA022409, KA022410, KA022411, KA022412, KA022413, KA022414, KA022415, KA022416, KA022417, KA022418, KA022419, KA022420, KA022421, KA022422, KA022423, KA022424, KA022425, KA022426, KA022427, KA022428, KA022429, KA022430, 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KA022588, KA022589, KA022590, KA022597, KA022598, KA022599, KA022600, KA022601, KA022602, KA022603, KA022604, KA022605, KA022606, KA022607, KA022608, KA022609, KA022611, KA022613, KA022615, KA022616, KA022617, KA022618, KA022620, KA022669, KA022670, KA022672, KA022675, KA022735, KA022738, KA022739, KA022740, KA022742, KA022749, KA022750, KA022751, KA022760, KA022785, KA022787, KA022792, KA022794, KA022796, KA022797, KA022798, KA022799, KA022800, KA022801, KA022804, KA022807, KA022817, KA022907, KA022910, KA022916, KA022918, KA022919, KA022921, KA022922, KA022923, KA022924, KA022925, KA022926, KA022927, KA022928, KA022929, KA022930, KA022931, KA022932, KA022941, KA022942, KA022944, KA022945, KA022946, KA022947, KA022948, KA022949, KA022950, KA022951, KA022952, KA022953, KA022954, KA022955, KA022956, KA022957, KA022959, KA022960, KA022961, KA022962, KA022963, KA022964, KA022965, KA022966, KA022967, KA022968, KA022969, KA022970, KA022971, KA022972, KA022977, KA022978, KA022979, KA022980, KA022981, KA022982, KA022983, KA022987, KA022988, KA022989, KA022990, KA022991, KA022992, KA022993, KA022994, KA022995, KA022996, KA022997, KA022998, KA022999, KA023000, KA023001, KA023002, KA023003, KA023004, KA023005, KA023006, KA023007, KA023008, KA023009, KA023010, KA023011, KA023012, KA023013, KA023014, KA023015, KA023016, KA023017, KA023018, KA023019, KA023020, KA023021, KA023022, KA023023, KA023024, KA023025, KA023026, KA023027, KA023028, KA023029, KA023030, KA023031, KA023032, KA023033, KA023034, KA023035, KA023036, KA023037, KA023038, KA023039, KA023040, KA023041, KA023042, KA023043, KA023044, KA023045, KA023046, KA023047, KA023048, KA023049, KA023050, KA023051, KA023052, KA023053, KA023054, KA023055, KA023056, KA023059, KA023060, KA023062, KA023066, KA023074, KA023076, KA023077, KA023079, KA023138, KA023143, KA023144, KA023145, KA023146, KA023147, KA023148, KA023149, KA023150, KA023151, KA023169, KA023170, KA023171, KA023173, KA023174, KA023175, KA023176, KA023177, KA023178, 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KA024111, KA024112, KA024113, KA024114, KA024115, KA024116, KA024117, KA024118, KA024119, KA024120, KA024121, KA024122, KA024123, KA024124, KA024125, KA024126, KA024127, KA024128, KA024129, KA024130, KA024131, KA024132, KA024133, KA024134, KA024135, KA024136, KA024137, KA024138, KA024139, KA024140, KA024141, KA024142, KA024143, KA024144, KA024146, KA024147, KA024148, KA024149, KA024150, KA024151, KA024152, KA024153, KA024154, KA024155, KA024156, KA024157, KA024158, KA024159, KA024160, KA024161, KA024162, KA024163, KA024164, KA024165, KA024166, KA024167, KA024168, KA024169, KA024170, KA024172, KA024173, KA024174, KA024175, KA024176, KA024177, KA024178, KA024179, KA024180, KA024181, KA024182, KA024183, KA024184, KA024185, KA024186, KA024187, KA024188, KA024189, KA024190, KA024191, KA024192, KA024194, KA024195, KA024196, KA024197, KA024198, KA024199, KA024213, KA024223, KA024224, KA024226, KA024234, KA024238, KA024242, KA024243, KA024254, KA024261, KA024262, KA024265, KA024266, KA024268, 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• Recalling Firm/ Manufacturer: Welch Allyn Protocol, Inc; 8500 Sw Creekside Pl; Beaverton OR 97008
• For Additional Information Contact: Welch Allyn Technical Support; 503-530-7935
• Manufacturer Reason for Recall: Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
• FDA Determined Cause: Device Design
• Action: Welch Allyn began sending out the Urgent Medical Device Correction letter, dated December 03, 2013, to consignees on December 10, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer Actions: In the unlikely event that operation of your Propaq LT is interrupted and the display becomes blank or white, pressing the power (on/off) button will restart the device and quickly bring it back to full operational capacity. This notice should be passed on to all those who need to be aware within your organization, or to any organization where the potentially affected devices have been transferred. Welch Allyn is in the process of developing a software installation service tool that will enable installation of the software update by your biomed, IT staff or other technically qualified personnel. Upon release, the service tool will be made available to you via a download from Welch Allyn's website at www.welchallyn.com/PropaqltUpgrade or other media. In the meantime and on an on-going basis, the software update will be included if you schedule routine or other service with Welch Allyn or an authorized service provider. Customers with questions were instructed to call Welch Allyn Technical Support at 1-800-535-6663. For questions regarding this recall call 503-530-7935.
• Quantity in Commerce: 6003 units total (1715 units in the US and 4288 outside the US)
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
• 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 = MWI and Original Applicant = WELCH ALLYN PROTOCOL, INC.