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FDAFDA · Food and drugs·Recall number Z-0633-2014

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.

Published January 15, 2014 · Recall initiated: November 21, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Welch Allyn Protocol, Inc
Distributor
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.
Lot
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, KA021403, KA021406, KA021407, KA021408, KA021410, KA021413, KA021415, KA021417, KA021419, KA021426, KA021427, KA021429, KA021462, KA021465, KA021466, KA021469, KA021486, KA021492, KA021495, KA021503, KA021511, KA021516, KA021522, KA021524, KA021529, KA021531, KA021534, KA021545, KA021546, KA021547, KA021549, KA021552, KA021553, KA021556, KA021557, KA021558, KA021559, KA021560, KA021562, KA021563, KA021564, KA021565, KA021566, KA021567, KA021568, KA021569, KA021570, KA021572, KA021576, KA021587, KA021588, KA021589, KA021590, KA021591, KA021592, KA021598, KA021606, KA021609, KA021611, KA021613, KA021614, KA021615, KA021616, KA021623, KA021624, KA021626, KA021630, KA021632, KA021635, KA021670, KA021679, KA021702, KA021704, KA021705, KA021706, KA021707, KA021708, KA021709, KA021711, KA021713, KA021714, KA021715, KA021716, KA021722, KA021723, KA021741, KA021742, KA021745, KA021746, KA021748, KA021749, KA021750, KA021765, KA021766, KA021786, KA021787, KA021788, KA021790, KA021799, KA021803, KA021804, KA021805
Risk classification
Class II
Area (FDA)
device
Country
United States

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