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
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.