Avalon Ultrasound Transducer. Directs low-energy recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. 867246; UDI: 00884838093195; Serial No. DE67535433, DE67535436, DE67535443, DE67535447, DE67535452, DE67535462, DE67535463, DE67535464, DE67535470, DE67535471, DE67535474, DE67535476, DE67535479, DE67535480, DE67535483, DE67535484, DE67535487, DE67535488, DE67535499, DE67535502, DE67535507, DE67535508, DE67535518, DE67535521, DE67535523, DE67535527, DE67535529, DE67535530, DE67535533, DE67535536, DE67535538, DE67535540, DE67535542, DE67535546, DE67535547, DE67535556, DE67535562, DE67535564, DE67535566, DE67535569, DE67535570, DE67535572, DE67535574, DE67535580, DE67535581, DE67535584, DE67535587, DE67535589, DE67535591, DE67535592, DE67535598, DE67535604, DE67535605, DE67535606, DE67535623, DE67535636, DE67535646, DE67535667, DE67535711, DE67535712, DE67535717, DE67535718, DE67535721, DE67535731, DE67535732, DE67535736, DE67535740, DE67535746, DE67535754, DE67535755, DE67535759, DE67535761, DE67535826, DE67535830, DE67535831, DE67535856, DE67535860, DE67535864, DE67535873, DE67535879, DE67535881, DE67535883, DE67535884, DE67535885, DE67535888, DE67535894, DE67535904, DE67535909, DE67535911, DE67535918, DE67535920, DE67535923, DE67535927, DE67535932, DE67535949, DE67535962, DE67535964, DE67535978, DE67535994, DE67536005, DE67536015, DE67536018, DE67536021, DE67536047, DE67536051, DE67536055, DE67536065, DE67536083, DE67536108, DE67536116, DE67536123, DE67536136, DE67536137, DE67536140, DE67536148, DE67536180, DE67536191, DE67536207, DE67536208, DE67536211, DE67536212, DE67536223, DE67536233, DE67536245, DE67536248, DE67536249, DE67536252, DE67536258, DE67536269, DE67536272, DE67536273, DE67536274, DE67536280, DE67536288, DE67536303, DE67536304, DE67536307, DE67536313, DE67536315, DE67536332, DE67536333, DE67536339, DE67536347, DE67536357, DE67536358, DE67536390, DE67536392, DE67536397, DE67536400, DE67536404, DE67536406, DE67536409, DE67536411, DE67536434, DE67536443, DE67536451, DE67536452, DE67536453, DE67536459, DE67536463, DE67536465, DE67536471, DE67536475, DE67536479, DE67536485, DE67536486, DE67536489, DE67536501, DE67536509, DE67536512, DE67536519, DE67536539, DE67536540, DE67536592, DE67536602, DE67536614, DE67536626, DE67536659, DE67536668, DE67536742, DE67536749, DE67536750, DE67536761, DE67536765, DE67536768, DE67536809, DE67536813, DE67536823, DE67536834, DE67536837, DE67536843, DE67536851, DE67536856, DE67536867, DE67536910, DE67536937, DE67536940, DE67536954, DE67536976, DE67536979, DE67536981, DE67536982, DE67536989, DE67536994, DE67536997, DE67536999, DE67537005, DE67537012, DE67537037, DE67537038, DE67537058, DE67537070, DE67537074, DE67537077, DE67537078, DE67537085, DE67537086, DE67537092, DE67537124, DE67537130, DE67537141, DE67537147, DE67537151, DE67537154, DE67537228, DE67537233, DE67537234, DE67537236, DE67537239, DE67537250, DE67537259, DE67537268, DE67537274, DE67537309, DE67537311, DE67537319, DE67537336, DE67537351, DE67537368, DE67537376, DE67537378, DE67537419, DE67537491, DE67537500, DE67537501, DE67537513, DE67537520, DE67537525, DE67537557, DE67537572, DE67537575, DE67537583, DE67537589, DE67537600, DE67537604, DE67537605, DE67537608, DE67537611, DE67537612, DE67537616, DE67537617, DE67537623, DE67537627, DE67537630, DE67537635, DE67537647, DE67537659, DE67537660, DE67537661, DE67537673, DE67537684, DE67537687, DE67537696, DE67537701, DE67537702, DE67537703, DE67537704, DE67537708, DE67537719, DE67537728, DE67537730, DE67537735, DE67537756, DE67537757, DE67537759, DE67537771, DE67537772, DE67537776, DE67537779, DE67537789, DE67537795, DE67537800, DE67537813, DE67537814, DE67537816, DE67537820, DE67537827, DE67537828, DE67537844, DE67537860, DE67537862, DE67537869, DE67537873, DE67537876, DE67537882, DE67537885, DE67537890, DE67537893, DE67537897, DE67537898, DE67537931, DE67537962, DE67537972, DE67537973, DE67537975, DE67537980, DE67537988, DE67537990, DE67538007, DE67538012, DE67538023, DE67538030, DE67538035, DE67538036, DE67538038, DE67538042, DE67538043, DE67538045, DE67538090, DE67538095, DE67538097, DE67538104, DE67538120, DE67538121, DE67538126, DE67538129, DE67538146, DE67538154, DE67538156, DE67538175, DE67538184, DE67538187, DE67538197, DE67538208, DE67538214, DE67538215, DE67538227, DE67538232, DE67538244, DE67538247, DE67538248, DE67538252, DE67538253, DE67538267, DE67538271, DE67538274, DE67538289, DE67538291, DE67538296, DE67538299, DE67538300, DE67538302, DE67538303, DE67538320, DE67538335, DE67538338, DE67538344, DE67538347, DE67538350, DE67538357, DE67538362, DE67538363, DE67538364, DE67538371, DE67538373, DE67538383, DE67538384, DE67538385, DE67538392, DE67538393, DE67538394, DE67538397, DE67538407, DE67538410, DE67538441, DE67538447, DE67538457, DE67538464, DE67538466, DE67538475, DE67538489, DE67538567, DE67538592, DE67538615, DE67538680, DE67538714, DE67538738, DE67538751, DE67538754, DE67538774, DE67538783, DE67538792, DE67538799, DE67538801, DE67538806, DE67538817, DE67538818, DE67538847, DE67538851, DE67538860, DE67538917, DE67538919, DE67538921, DE67538924, DE67538933, DE67538950, DE67538952, DE67538992, DE67538993, DE67538996, DE67538998, DE67539000, DE67539002, DE67539005, DE67539008, DE67539009, DE67539014, DE67539017, DE67539020, DE67539030, DE67539032, DE67539039, DE67539071, DE67539083, DE67539090, DE67539094, DE67539100, DE67539103, DE67539136, DE67539144, DE67539153, DE67539172, DE67539186, DE67539193, DE67539197, DE67539206, DE67539213, DE67539226, DE67539258, DE67539292, DE67539293, DE67539295, DE67539302, DE67539303, DE67539304, DE67539306, DE67539313, DE67539316, DE67539317, DE67539319, DE67539333, DE67539341, DE67539343, DE67539349, DE67539351, DE67539352, DE67539356, DE67539393, DE67539407, DE67539438, DE67539477, DE67539494, DE67539505, DE67539590, DE67539622, DE67539639, DE67539641, DE67539667, DE67539673, DE67539686, DE67539695, DE67539707, DE67539708, DE67539713, DE67539718, DE67539720, DE67539737, DE67539765, DE67539767, DE67539774, DE67539776, DE67539785, DE67539799, DE67539800, DE67539804, DE67539806, DE67539809, DE67539813, DE67539828, DE67539832, DE67539846, DE67539848, DE67539862, DE67539866, DE67539879, DE67539905, DE67539923, DE67539957, DE67539972, DE67539976, DE67539977, DE67539990, DE67539991, DE67540003, DE67540012, DE67540025, DE67540084, DE67540090, DE67540095, DE67540154, DE67540161, DE67540169, DE67540195, DE67540204, DE67540206, DE67540212, DE67540221, DE67540222, DE67540223, DE67540242, DE67540251, DE67540265, DE67540269, DE67540301, DE67540302, DE67540347, DE67540373, DE67540401, DE67540408, DE67540409, DE67540418, DE67540438, DE67540440, DE67540442, DE67540446, DE67540459, DE67540462, DE67540469, DE67540487, DE67540511, DE67540519, DE67540530, DE67540545, DE67540547, DE67540548, DE67540550, DE67540554, DE67540557, DE67540559, DE67540564, DE67540569, DE67540601, DE67540603, DE67540605, DE67540617, DE67540623, DE67540626, DE67540636, DE67540638, DE67540641, DE67540667, DE67540673, DE67540677, DE67540679, DE67540685, DE67540696, DE67540704, DE67540709, DE67540719, DE67540752, DE67540758, DE67540768, DE67540776, DE67540780, DE67540784, DE67540819, DE67540826, DE67540835, DE67540865, DE67540890, DE67540912, DE67540913, DE67541005, DE67541010, DE67541019, DE67541048, DE67541062, DE67541063, DE67541129, DE67541140, DE67541145, DE67541159, DE67541169, DE67541175, DE67541187, DE67541192, DE67541219, DE67541224, DE67541231, DE67541232, DE67541245, DE67541246, DE67541248, DE67541265, DE67541275, DE67541283, DE67541297, DE67541307, DE67541353, DE67541406, DE67541437, DE67541456, DE67541473, DE67541477, DE67541512, DE67541528, DE67541549, DE67541550, DE67541554, DE67541588, DE67541589, DE67541599, DE67541607, DE67541653, DE67541666, DE67541679, DE67541704, DE67541729, DE67541739, DE67541746, DE67541758, DE67541760, DE67541771, DE67541779, DE67541780, DE67541791, DE67541795, DE67541798, DE67541831, DE67541846, DE67541856, DE67541861, DE67541868, DE67541873, DE67541884, DE67541885, DE67541910, DE67541914, DE67541970, DE67541973, DE67541987, DE67542010, DE67542017, DE67542025, DE67542051, DE67542053, DE67542091, DE67542099, DE67542122, DE67542130, DE67542140, DE67542150, DE67542180, DE67542198, DE67542212, DE67542231, DE67542239, DE67542276, DE67542277, DE67542293, DE67542299, DE67542301, DE67542322, DE67542326, DE67542366, DE67542370, DE67542395, DE67542422, DE67542438, DE67542445, DE67542455, DE67542472, DE67542485, DE67542494, DE67542509, DE67542535, DE67542542, DE67542553, DE67542555, DE67542556, DE67542560, DE67542585, DE67542591, DE67542605, DE67542639, DE67542655, DE67542664, DE67542669, DE67542675, DE67542701, DE67542704, DE67542707, DE67542720, DE67542724, DE67542733, DE67542744, DE67542759, DE67542763, DE67542784, DE67542792, DE67542793, DE67542819, DE67542839, DE67542857, DE67542934, DE67542939, DE67542955, DE67543000, DE67543028, DE67543030, DE67543043, DE67543118, DE67543185, DE67543249, DE67543267, DE67543288, DE67543313, DE67543315, DE67543382, DE67543392, DE67543424, DE67543456, DE67543506, DE67543508, DE67543509, DE67543525, DE67543551, DE67543579, DE67543586, DE67543590, DE67543608, DE67543761, DE67543767, DE67543784, DE67543825, DE67543868, DE67543932, DE67543936, DE67544160, DE67544179, DE67544196, DE67544221, DE67544235, DE67544263, DE67544273, DE67544275, DE67544279, DE67544303, DE67544386, DE67544415.

Product

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

Recalling firm

Philips North America Llc

Quantity

6,915 units

Distribution

Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT, AU, BA, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GI, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KE, KW, LB, LK, LS, LT, LU, LV, LY, MA, ME, MT, MU, MY, NA, NI, NL, NZ, OM, PA, PH, PK, PL, PR, PS, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, VN, ZA.

Recall date

July 10, 2024

Classification

Class II

Status

Ongoing

Agency

FDA (device)