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FDAFDA · Food and drugs·Recall number Z-2239-2024

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

Published July 10, 2024 · Recall initiated: May 22, 2024

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

What's the hazard

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Philips North America Llc
Distributor
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.
Lot
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, DE
Risk classification
Class II
Area (FDA)
device
Country
United States

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