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Philips North America Llc recalls Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal he
Recalled July 10, 2024 · FDA recall Z-2239-2024 · Philips North America
Hazard
Potential for inaccurate fetal heart rate measurements when monitoring multiples. · FDA Class II
Units
6,915 units
Sold at
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.
Description
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Product
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →