Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
This recall is currently active, issued June 28, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- May 22, 2024
- Posted
- June 28, 2024
- Recall Number
- Z-2239-2024
- Quantity
- 6,915 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
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.
Lot / Code Info
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, 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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, 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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.
Root Cause
Component change control
Action Taken
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.