Open, Classified

Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.

FDA Recall Z-2239-2024 · Posted 2024-06-28

Recalling FirmPhilips North America Llc

Recall StatusOpen, Classified

Product CodeHGM

Date Initiated2024-05-22

Product Quantity6,915 units

Reason for Recall

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Firm Action

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.

Root Cause

Component change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.