FDA-Device2024-07-10Class II
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Philips North America Llc
Hazard
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Sold states
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.
Affected count
6,915 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2024Don't want to check this manually?
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