Medical Device Recall: Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Philips North America Llc · May 22, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
6,915 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2239-2024
Status: ongoing
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