Skip to content

Avalon Ultrasound Transducer. Directs low-energy ultrasound… recallZ-2239-2024 · Philips North America Llc · initiated May 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

FDA root cause category: Component change control

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notice dated 5/22/2024 was mailed to consignees. Consignees are instructed to identify what software their Avalon wired transducers. Avalon wired transducers with software revision L.01.04 must not be used when monitoring multiples and can only be safely used when monitoring the fetal heart rate of singletons. Avalon wired transducers that do not possess the affected software revision can be used when monitoring twins or triplets. An alternative to the Avalon wired Transducer is using the wireless Avalon CL Ultrasound transducer. Consignees are to complete and return the provided response form at recall.responsephilips.com or by fax to 877-499-7223. The provided recall notification should be shared with all clinical staff and kept with the documentation of the Avalon ultrasound transducer. Consignees with questions should contact their local Philips representative or call 1-800-722-9377.

Recall details

Recall number
Z-2239-2024
Status
Open, Classified
Initiated by the company
May 22, 2024
Posted by the FDA
Jun 28, 2024
Recalling firm
Philips North America Llc
Quantity
6,915 units
Product code
HGM
FDA submissions
K140535
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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (9k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page