Recall archive / FDA device enforcement

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal... — FDA record Z-2239-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Reason: Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Classification: Class II
Recalling firm: Philips North America Llc
Quantity: 6,915 units
Agency-reported status: Ongoing
Source record identifier: Z-2239-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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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, 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Label field

Details supplied by the agency

Lot, code or applicability

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, 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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.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 10, 2024
Recall initiation date: May 22, 2024
Center classification date: Jun 28, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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